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In this episode of The Cancer Letter Podcast, Paul Goldberg, editor and publisher of The Cancer Letter, and Jacquelyn Cobb, managing editor, discuss promising developments in cancer research and the growing prominence of cancer as an election issue in Iowa.  Jaqcuelyn’s conversation with Kevan Shokat, the pioneering chemist whose work helped transform the once undruggable KRAS protein into a therapeutic target, took the stage in this episode. “[Kevan Shokat] was very much like a celebrity to me. He made KRAS druggable… He made the undruggable druggable, so it was this big exciting thing. And then I talked to him, and it was such a great, awesome, cool conversation,” Jacquelyn said. “So, I'll dive into more details about that, but he won the [Stephenson] prize, and so that basically gave me an excuse to give a roundup of what the state of RAS, KRAS specifically, research is looking like right now, which is blown up ever since daraxonrasib had the really great results.” It was when Shokat and his team looked at the KRAS problem as a chemistry problem rather than a biology problem, they were able to crack the code.  “He has a really cool quote there where he's like, ‘Once we figured out that it was a chemistry problem, I knew it was going to work. We just had to figure out how,’” Jacquelyn said. Meanwhile, cancer is becoming an increasingly prominent political issue. Iowa has ranked second in the nation for new cancer cases for three consecutive years, and incidences are rising faster than in any other state, and politicians and policymakers take notice.  “It's kind of that political cliche, as Iowa goes, so goes the nation,” Paul said. “Unfortunately, it's not true when it comes to cancer statistics, because as national cancer numbers are receding slowly, Iowas are increasing for whatever reason. And the interesting story here is that cancer suddenly became a huge political issue. It's the first question asked at political debates during the midterms, and that's really the story. What does it mean? People care about oncology, they do. Well, nationally, look, the administration tried to cut NIH budget severely, including NCI budget, and it failed, and it seems to have kind of recognized its failure, so perhaps hands off.” Jacquelyn and Paul examine how cancer is shaping electoral conversations in Iowa, and what that could mean for cancer policy.

With the pope’s lung cancer diagnosis jumpstarting conversations about lung cancer screening, and the constant buzz surrounding multi-cancer detection tests, evidence-based evaluation of screening tests is more important than ever, Paul Goldberg, editor and publisher of The Cancer Letter, and Jacquelyn Cobb, managing editor, discussed in this episode of The Cancer Letter Podcast. “This idea that screening is always good is probably gaining traction right now for the lack of places that can evaluate these tests,” Paul said. “If you trust FDA on this, well, FDA is not going to tell you if you're going to benefit, if you stand to benefit. NCI will tell you—if NCI has the resources to do this trial, which it should. We're not entitled to opinions on many issues, but a clinical trial is better than no clinical trial.” Also, the U.S. Preventive Services Task Force is currently at risk of losing the expertise, evidence-review infrastructure, and institutional culture that has made it a trusted model for evidence-based medicine.  “Right now the task force is in the process of being destroyed,” David Ransohoff, a gastroenterologist and clinical epidemiologist in the Division of Gastroenterology and Hepatology at University of North Carolina School of Medicine, said in a conversation with The Cancer Letter published in last week’s issue. “And if we lose the task force, we lose an important institution that was the exemplar of evidence-based medicine.” Ransohoff predicts a “Wild West” era without evidence-based screening guidelines. “Right now, it's not the Wild West,” Paul said. “We're still in the prairies of the Midwest and the Wild West comes a little bit later. We're in the cornfields of Iowa. The Wild West is when you cross the Mississippi.  “So, we're crossing the Mississippi.” Stories mentioned in this podcast include:  VCU’s Baskin and UNC’s Ferris weigh oncology’s looming dilemma—MCDs Center directors are strategizing for likely FDA approval of GRAIL’s Galleri  As trust in USPSTF erodes, cancer screening is in peril David Ransohoff predicts a “Wild West” era without evidence-based screening guidelines  Rachna Shroff, accomplished GI oncologist and “tireless mentor,” dies at 47 Her endowed award will live on  The lung cancer diagnosis of Pope Leo—believed to be a never-smoker—sparks conversations around screening  A transcript of this podcast is available: https://cancerletter.com/podcastc/20261021-uspstf/

As the Galleri test is advancing toward becoming the first multi-cancer detection test to secure FDA approval, cancer care providers are coming up with strategies for using these tests responsibly.  How will cancer centers counsel patients who walk through the doors with MCD test results? Under what circumstances can cancer physicians rely on this technology? What role will they play in determining the potential of these tests to affect health outcomes? These burning questions were front and center on the October episode of The Directors, a monthly series on The Cancer Letter Podcast which focuses on the problems that keep directors of cancer centers up at night.  “I think there’s room for us to have some caution, because we still don’t know what [a Galleri result] is actually saying,” Monica L. Baskin, director of VCU Massey Cancer Center, said in the October episode of The Directors. “It sort of signals that something is there, but the key is really in the follow-up. How can we really go in and have the diagnostics to understand?” Baskin appeared on The Directors with Robert L. Ferris, executive director of the UNC Lineberger Comprehensive Cancer Center and chief of Oncology Clinical Services for UNC Health. The podcast is moderated by Paul Goldberg, editor and publisher of The Cancer Letter and sponsored by the American Society of Clinical Oncology. VCU and UNC are among the sites of the NCI Vanguard trial, which seeks to gauge the impact of the Avantect and Shield tests (not the Galleri test) and the patient benefit they can provide. The tests are called alternatively the multicancer detection tests—called MCDs for short—or multicancer early detection tests—or MCEDs. Read more and access the full transcript: https://cancerletter.com/podcastc/20261016_1/

As the oncology community waits with bated breath for a possible FDA approval of GRAIL’s Galleri test, NCI Director Anthony Letai has a lot to say about multi-cancer detection tests—particularly Galleri.  Letai spoke at a National Comprehensive Cancer Network policy summit on screening and prevention last week on Oct. 6. “It’s very important when we consider screening studies that we don’t, in our minds, project the ideal screening test that we have in mind, but actually the real test that we have on hand,” Letai said at the summit. “Even though we aspire to ideal tests, projecting sub-ideal tests across a large population can cause harm—both financial and real, physical harm.” In this episode of The Cancer Letter Podcast, Paul Goldberg, editor and publisher of The Cancer Letter, and Sara Willa Ernst, reporter, discuss Letai’s remarks. FDA approval for Galleri seems likely after an advisory committee voted in favor of the test during a Sept. 23 meeting. “Now we’re waiting. What will FDA do when they have this recommendation from the advisory committee?” Sara said.  The FDA panel voted that the test was safe, effective, and that the benefits outweigh the risks. This recommendation did not consider questions of clinical benefit.  “FDA seems to be perfectly happy with sidestepping the question of benefit,” Paul said. “If FDA is not going to care about patient benefit in this case, who does?” Letai’s comments about MCDs were “very consistent with what Phil Castle, the director of the [NCI] Division of Cancer Prevention, was saying—basically, who is going to ask questions of patient benefit?” Paul said.  If Galleri is approved by FDA, the test may sail down a shorter path to widespread Medicare coverage and bypass the usual need for a recommendation by the U.S. Preventative Services Task Force, which usually takes years.  “I have some concerns about this,” Letai said about the panel’s vote. “My concerns are that people overestimate the performance of this assay.”  This episode is sponsored by City of Hope. Learn more at www.cityofhope.org. Stories mentioned in this podcast include: Letai: MCEDs are a “great ideal”—alas, the data don’t support widespread use Oncologist Rachna Shroff endows award to outlast her cancer diagnosis Cancer vaccine policy in limbo as CDC keeps canceling advisory meetings Oncology has a semantics problem: How do we define “early stage”? MUSC startup brings preclinical imaging into the light A transcript of this podcast is available: https://cancerletter.com/podcastc/20261014-galleri/

“I don’t know of a single grant that left my desk that was not approved and funded,” NCI Director Anthony G. Letai said on this episode of The Cancer Letter Podcast. Letai recapped his first year as NCI director in conversation with Paul Goldberg, editor and publisher of The Cancer Letter, and laid out his priorities for the year ahead.  In the conversation, Letai discusses his goal of calming uncertainty at the institute, and why he hopes the metrics from his first year as director—which he lays out in detail—will change the way NCI is portrayed by the media.  “I hope I don’t see any more reports of NCI cutting funding, because it just is not consistent with the facts,” Letai said.  NCI has given away all the money it intended to, Letai told Paul.  “He's saying that NCI has not been cut back,” Paul said. “In fact, it's giving out more money and more grants than ever before. So, that's reality.” While NCI is reporting thriving extramural research spending, that is not to say that the Trump administration hasn’t attempted—and succeeded in making—a litany of policy actions that imperil the cancer research enterprise, Paul said.  “[Letai] calmed the thing down,” Paul said. “He calmed the place down. But also, I don't want to sound like everything is great or that I think everything is great. I mean, the administration really did try to cut NCI and NIH by about 40%, and the Republicans in Congress and Democrats in Congress stopped that. So, there's that. And we've been covering efforts by OMB to put in political review of grants essentially, and all funding. That's not happened. There was just a few weeks ago actually a discussion of an executive order which has not been issued. Well, we'll see what happens after the midterms. “So, I mean, we're just covering politics, but we have to be realistic about what's actually happening and what's not happening. And what's not happening is the cutbacks in cancer research.” Letai credited NCI staff with the institute’s success in getting extramural funding out the door during a tumultuous time.  “These are all record-high numbers. And it’s a real tribute, I think, in a challenging year, that the NCI staff, despite a lot of public doubt, just kept their nose to the grindstone and week after week, month after month, did their job, as I said they were doing.” Stories mentioned in this podcast include:  With Year One metrics in hand, Letai is ready to “bring it home” in Year Two Michael Caputo appointed to President’s Cancer Panel Two years after FDA’s breast density notification rule, there is still no standard for follow-up MD Anderson study suggests psilocybin may prevent chemo-induced neuropathy A transcript of this podcast is available: https://cancerletter.com/podcastc/20261007-letai/

In this episode of The Cancer Letter Podcast, Paul Goldberg, editor and publisher of The Cancer Letter, Jacquelyn Cobb, managing editor, discuss the Sept. 23 meeting of the FDA Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee, during which the panel voted in favor of Galleri, the multi-cancer detection test from GRAIL Inc., to become the first multi-cancer detection test to receive regulatory approval. At the advisory committee meeting, FDA put to rest the question of how it will assess multi-cancer screening tests. Reduction in mortality as shown through a randomized controlled trial, the standard measure of clinical benefit for a screening test will not be considered for approval of Galleri, FDA said. Surrogate metrics for clinical benefit, such as stage shift, would not be considered as part of the PMA, either, the agency said. “The problem with this thing is how many science writers actually understand the subtle concepts we're kicking around here right now? The answer is not many. How many doctors understand it? The answer is not many. What will happen to patients? And that's where I kind of lose sleep. So, people get that test because they're nervous, because they're cancer-phobic, which is a reasonable thing. I have it. Cancer-phobia, I have a bad case.” The agency repeatedly told the panel members to limit the scope of discussion to the ability of Galleri to detect cancers in asymptomatic individuals. The advisors were instructed not to get stumped on questions of whether the test can provide any clinical benefit, such as a decrease in mortality. In this episode of The Cancer Letter Podcast, you can hear this exchange first-hand. This episode is sponsored by Fox Chase Cancer Center. Learn more at https://www.foxchase.org/discovery. Stories mentioned in this podcast include: The Directors: Two Gulf Coast cancer center directors on why NCI designation matters—and why they want it Lucio Miele and Raghu Kalluri FDA advisory committee votes in favor of Galleri approval, but calls for removal of “early” detection claims Trump weighs—and abandons—an executive order that would give OMB veto power over NIH grants  When did stage 3B lung cancer become “early stage”? How biology is reshaping breast cancer care At confirmation hearing, Heidi Overton sidesteps questions about FDA regulation of fruit-flavored vapes

What should a cancer center look like in an era of AI, genomics, complex patient populations, rising costs, and declining public trust in science? Two directors—both pursuing NCI designations, and serving contiguous Gulf Coast catchment areas—offer profound thoughts on the matter of building a modern cancer center.  Raghu Kalluri, senior vice president, executive director, and chief scientific officer of the University of Texas Medical Branch Cancer Center, and Lucio Miele, director of Louisiana State University-LCMC Health Cancer Center, are thinking about what a cancer center should look like over the next 50-100 years.  “There's a tremendous catchment out there of people who are interested in doing something new, doing something different. And I'm one of them. For me, this is a great opportunity that leadership presented from the UTMB to the University of Texas system, and it was a great opportunity to go do something new,” said Kalluri, who joined UTMB from the University of Texas MD Anderson Cancer Center, where he served as professor and chair of Cancer Biology and director of the Metastasis Research Center. Rather than treating the current revolution in science and medicine as a threat, Kalluri and Miele see it as an opportunity to do more than just replicate existing models. “I'm finding the exact same thing. Finding people who are interested in doing something new in an environment where they have room to grow is possible and not particularly difficult in this day and age, given sufficient resources. So, yes, this is a good time to start the cancer center, paradoxically—despite all the challenges,” said Miele, who is also a senior associate dean for research at LSU Health New Orleans School of Medicine, chair of the Department of Genetics, and Cancer Crusaders Professor of Genetics. Kalluri and Miele appeared together on The Directors, a monthly series which focuses on the problems that keep directors of cancer centers up at night. Read more and access the full episode transcript: https://cancerletter.com/podcastc/20260925_1/

In this episode of The Cancer Letter Podcast, Fran Visco, president of the National Breast Cancer Coalition, and Jacquelyn Cobb, managing editor of The Cancer Letter, discuss the Metastatic Breast Cancer Act, bipartisan legislation that would eliminate the waiting periods for Social Security Disability Insurance and Medicare for eligible people with metastatic breast cancer.  “We realized a number of years ago that women and men with metastatic breast cancer can have access to Social Security Disability and Medicare, regardless of age, that they automatically qualify. It's a qualifying condition under SSDI. We also realized that there is a wait time. There is a four month wait for Social Security Disability and then 24 month wait for Medicare. And this is in a population that has an average lifespan of about 36 months. So it made no sense to us, and I don't think I've spoken to anyone who told me it made sense to them, even on Capitol Hill,” Visco said.  Visco describes the real-life consequences of the waiting period, which includes patients with metastatic disease who continue to work despite being too sick to do so because they need employer-sponsored insurance to access lifesaving treatment.  “So why? We can't answer that question. We don't know why that happened. But the question we're asking now is why do they have to wait? This is ridiculous. We're not asking to expand an entitlement program or anything like that. They have paid for this benefit. They're entitled to it, and yet it's being withheld from them for some unknown reason, probably cost, and that is not a sufficient reason to deny a paid-for benefit to a dying group of people.” Visco said the legislation has attracted 268 bipartisan House cosponsors and support from about two-thirds of the Ways and Means Committee, but has yet to receive a markup.   “I can't understand how this country would allow it to happen, that women and men who are going through this, and who qualify for care, are not getting it,” said Visco. “Maybe we should call it a war and do something to get their attention because they seem to be able to fund wars quite well. So, how about funding something that can save lives?” This episode is sponsored by the American Society of Clinical Oncology. Learn more at https://quality.asco.org/ Stories mentioned in this podcast include: Scientific progress can’t help people if they can’t access care NBCC’s open letter to Ways and Means demands markup for Metastatic Breast Cancer Access to Care Act A transcript of this podcast is available: https://cancerletter.com/podcastc/20260923-ssdi/

This week’s oncology headlines run the gamut—from a discussion on the long-term consequences of 9/11 on lung cancer incidence, to the promise—and limits—of cutting edge mRNA science, to major institutional leadership changes, and even the intersection of cancer and war.  In this episode of The Cancer Letter Podcast, Paul Goldberg, editor and publisher with The Cancer Letter, and Jacquelyn Cobb, managing editor, discuss the 25th anniversary of the 9/11 attacks in relation to toxic exposure and cancer risk. The surprising finding is that the expected increase in lung cancer has not emerged in the way researchers might have anticipated. This may be due in part to a smoking cessation program for first responders spearheaded by the World Trade Center Health Program. The program’s medical director, Michael Crane, appeared on a recent episode of the Cancer History Project Podcast. Paul and Jacqeulyn also discuss the potentially game changing topline data that has been announced by Moderna/Merck personalized mRNA melanoma vaccine. The results, if the data holds up, will mark a milestone for the field: the first positive phase III result for an individualized neoantigen therapy and, according to the companies, the first-ever phase III success for an mRNA cancer therapy. “I think everybody who's really gung-ho and heart-eyes, lovestruck with the idea of precision medicine, I think that this is just really, really exciting,” Jacquelyn said.  This podcast episode also covered some major leadership musical chairs happening at cancer centers—MD Anderson, Duke, and the University of Florida.  Lastly, this episode takes a sharp turn into the war in Ukraine. A Russian general identified by Ukrainian authorities as being responsible for directing the missile attack on a Kyiv children’s hospital has been shot in Russia.  As Paul says, “When your happiest story in the week is about the assassination of the gentleman in Saratov…That's the measure of the times we're in.” This episode is sponsored by City of Hope. Learn more at www.cityofhope.org. Stories mentioned in this podcast include: 25 years after 9/11, a smoking cessation program may have curbed lung cancer risk for first responders at Ground Zero mRNA vaccine for melanoma is hailed as a turning point in medicine Cancer leaders play “musical chairs” as executive jobs fill at top cancer centers Russian general tied to bombing Kyiv children’s hospital shot in apparent retribution hit This podcast says Michael Crane is at Mount Sinai. His full title is professor in the Department of Environmental Medicine at the Icahn School of Medicine at Mount Sinai, medical director of the Selikoff Centers for Occupational Health, and medical director of the WTC Health Program at Mount Sinai. A transcript of this podcast is available: cancerletter.com/podcastc/20260916-911/

Last month, FDA approved the RAS inhibitor, daraxonrasib, sponsored by Revolution Medicines Inc. and also known as Rasonque, for patients with metastatic pancreatic adenocarcinoma who have received at least one prior systemic therapy or are not candidates for multiagent systemic therapy. In this week’s episode of In the Headlines, Jacquelyn Cobb, associate editor with The Cancer Letter, speaks with Frank McCormick, a leader in the KRAS space, about the history of RAS and where the field might be going next. McCormick is also the David A. Wood Chair of Tumor Biology and Cancer Research and a professor in the Helen Diller Family Comprehensive Cancer Center and the Department of Cellular and Molecular Pharmacology at the University of California, San Francisco. In the pancreatic cancer world, McCormick expects the field to improve upon what has worked. “We hope that the drugs that hit KRAS directly, or allele specifically, will hit the protein harder and have less side effects, and therefore will give better clinical outcomes than daraxonrasib. That's a hope or an aspiration. And potentially be more easy to combine with other drugs to help make it even more potent. So that's I think what we're all hoping from the wave of drugs coming down the pipe. So those results will emerge over the next year or two probably from multiple places, including Rev Med themselves have their own second generation drugs which are more specific and so on. “So, it'll be a lot more and hopefully a lot better drugs even than daraxonrasib. So that's again, aspirational. As we see in most fields, the first drug is great, the next one's even better, and so on.” But there are other paths ahead that have opened up after the success of daraxonrasib. “Another frontier is in colorectal cancer, which is still pretty much white space in terms of target therapy for KRAS mutant, which is about 50% of all colorectal cancers. So, there's nuances around that also, but colorectal cancer, a lot of the tumors are driven by KRAS and a lot of people are now moving towards colorectal cancer, probably in combination with cetuximab and other drugs. But if we can make an impact on there as well, that'll hopefully crack that open as well. That would be another standing ovation at ASCO if someone could really increase survival in a big way in colorectal cancer.” Stories mentioned in this podcast include:   KRAS pioneer and Stephenson Prize winner Frank McCormick aims to prevent all KRAS cancers with a pill  Pancreatic cancer finally starts to budge as daraxonrasib doubles overall survival The story of daraxonrasib is the ultimate hero’s journey A narrative curve with twists, turns, intrigue, drama—and a blow to a mighty foe  FDA permits expanded access for investigational pancreatic cancer drug daraxonrasib Long-awaited results from first phase III trial of a RAS inhibitor in pancreatic cancer shows that daraxonrasib doubles median OS PanCAN’s Berkenblit Zoldonrasib + daraxonrasib show 81% ORR in patients with RAS G12D metastatic pancreatic cancer, phase I/II study finds  A transcript of this podcast is available: https://cancerletter.com/podcastc/20260909-daraxonrasib/

On Aug. 26, FDA approved the RAS inhibitor, daraxonrasib, sponsored by Revolution Medicines Inc. and also known as Rasonque, for patients with metastatic pancreatic adenocarcinoma who have received at least one prior systemic therapy or are not candidates for multiagent systemic therapy. The approval was much anticipated by patients and clinicians alike, ever since the dramatic results of the RASolute-302 trial, a randomized, open-label, multicenter clinical trial involving 500 adults with previously treated metastatic pancreatic adenocarcinoma, were published. In the trial, daraxonrasib nearly doubled median overall survival to 13.2 months compared to 6.7 months for standard chemotherapy, a historic increase in a disease whose overall survival has stagnated for decades.  In this week’s episode of In the Headlines, Jacquelyn Cobb, associate editor with The Cancer Letter, speaks with Brian M. Wolpin, principal investigator for the RASolute-302 trial about his involvement in the clinical testing of daraxonrasib, what the scientific milestone means for his patients, and what to look out for next in the pancreatic cancer research space. Wolpin is the director of the Hale Family Center for Pancreatic Cancer Research at Dana-Farber Cancer Institute. “This really is the future of the field, I think, which is: KRAS is sort of the director of the orchestra in pancreatic cancer,” Wolpin said. “Once you inhibit that, you can then go after so many other aspects of pancreatic cancer biology and use it, use these new medicines in a way that if they were given by themselves, they wouldn't work as well.” Stories mentioned in this podcast include:  Pancreatic cancer finally starts to budge as daraxonrasib doubles overall survival The story of daraxonrasib is the ultimate hero’s journey A narrative curve with twists, turns, intrigue, drama—and a blow to a mighty foe  FDA permits expanded access for investigational pancreatic cancer drug daraxonrasib Long-awaited results from first phase III trial of a RAS inhibitor in pancreatic cancer shows that daraxonrasib doubles median OS PanCAN’s Berkenblit Zoldonrasib + daraxonrasib show 81% ORR in patients with RAS G12D metastatic pancreatic cancer, phase I/II study finds  A transcript of this podcast is available: https://cancerletter.com/podcastc/20260902-daraxonrasib/

On July 21, President Donald Trump announced his latest set of sweeping tariffs on the pharmaceutical industry: a 200% levy on imported generic drugs by the year 2029.  Trump imposed tariffs on branded drugs in April, which were met with concern about increased drug costs and decreased U.S. competitiveness in the global drug development market. However, a more dire concern—a familiar one—is arising now that tariffs are extended to generics: Shortages. At the time of the announcement, Jacquelyn Cobb, associate editor with The Cancer Letter, wrote a story about the news with expert commentary from Marta Wosińska, a healthcare economist and senior fellow at the Brookings Institution Center on Health Policy. In this episode of The Cancer Letter Podcast, Jacquelyn speaks with Wosińska to drill deeper into the potential implications of Trump’s new tariffs on generic oncology drugs. In the conversation, Wosińska explains how tariffs will likely not be able to achieve the goals Trump hopes.  “This is yet another wrinkle in a really unstable system,” Wosińska said. “And whether or not tariffs are playing into this—and tariffs could potentially make things more challenging, you know. Onshoring is not necessarily going to solve our problem, because we have already a lot of domestic manufacturing, and it's really not a domestic versus foreign problem.” The problem is much more complicated, and shortages—particularly of generic drugs like platinum-based chemotherapies—are a persistent, crippling, and sometimes deadly problem in oncology. “What we do have is a very fragile system that's not reliable,” Wosińska said. “So, you know, setting tariffs aside, we have a broken system and we have to repair that system.”  Stories mentioned in this podcast include:  Trump plans a 200% tariff on imported generic drugs by 2029, raising fears of cancer drug shortages  A transcript of this podcast is available: https://cancerletter.com/podcastc/20260826-tariffs/

In last week’s issue of The Cancer Letter, Raja Flores wrote a guest editorial explaining how he, with his expertise in thoracic surgery, took issue with a nuance in a recent Keytruda commercial.  In this week’s episode of In the Headlines, Flores spoke with Paul Goldberg, editor and publisher of The Cancer Letter, to explain how his deep dive into the issue led him to discover a broader issue in oncology: How loose terminology among oncologists, however innocuous or inconsequential it might seem, could lead to patient harm. “When you look at early stage lung cancer, and for this particular commercial, as a surgeon, I'm concerned that if all patients, not 3As or stage 2s, but if stage 1s get neoadjuvant therapy, they may miss their shot at being cured.” The commercial advertises the utility of preoperative Keytruda for people with “early stage” lung cancer. The commercial is supported by data from a clinical trial and an FDA approval, but the oncology community’s loose terminology when it comes to staging (at least in lung cancer), seems to have led to the commercial targeting all “early stage” patients, when the data supports preoperative Keytruda for patients with stage 2 and 3 disease, not stage 1.  “That's the important point is that the commercial doesn't talk about what was in the supplemental forms of that paper that was published in The New England Journal of Medicine,” Flores said. “About one out of every five patients who underwent preoperative therapy, preoperative Keytruda, did not make it to surgery.” Flores researched the commercial’s history to understand how it got through the endless regulations that govern medical advertising. “I started doing my homework about this label of ‘early stage.’ And I tried to find out the first time it was used in the KEYNOTE-671 trial, the trial that the commercial is based on,” Flores said. “So, I went to clinicaltrials.org and I went to the first online publication of the trial and it said preoperative therapy for stage 2, stage 3A, and stage 3B. I said, ‘Okay, that doesn't say early stage.’ Then several months later, in an ASCO abstract, the same authors had down the same title, 2, 3A, 3B. But then, within the abstract, it mentioned for the first time, early stage lung cancer.  “Then I said, ‘Huh, interesting.’ Then when you go to the publication in The New England Journal of Medicine, in the title, it doesn't say 2, 3A, 3B. It says early stage lung cancer.  “Then I said, ‘How did this get passed by the FDA?’ Then I went to the FDA records and I looked in the FDA records and I could see that when this trial or when these drugs went up for their label, it didn't have a committee meeting. They felt that the data was compelling enough, and so it passed the FDA. “So, when you look at all the safeguards that we have in place: FDA, peer-reviewed process, The New England Journal of Medicine, clinical trials office, it completely missed this thing about early stage lung cancer.” This Keytruda commercial is only one iteration of a broader concern, Flores said.  “I'm in the middle of continuing to investigate this,” Flores said. “And in the end, I'm kind of concerned that we've gotten so loose with our oncologic terminology because if you're speaking to another doctor and you say early stage, they're going to say, ‘Well, what specific stage are you talking about?’ “It's actually something that has penetrated the oncologic culture for the past several decades. And I think it's time to shine a light on it and shift how we talk about it because it's confusing, at least confusing my patients,” Flores said.  This episode is sponsored by the American Society of Clinical Oncology. Learn more at asco.org/ascoaction. Stories mentioned in this podcast include:  Marketing hope before surgery: Does the new Keytruda commercial tell patients the whole story? A transcript of this podcast is available: https://cancerletter.com/podcastc/20260819-flores/

Last week, FDA granted accelerated approval to Replimune Group Inc. for it’s biologic, RP1 (vusolimogene oderparepvec), following the FDA Cellular, Tissue, and Gene Therapies Advisory Committee’s 10:3 vote in support of the biologic in combination with nivolumab for the treatment of advanced melanoma in patients who have progressed on prior anti-PD-1 therapy. The approval and the CTGTAC decision follows a years-long imbroglio with two previous applications for RP1 bouncing back to Replimune.  After the first Complete Response Letter from FDA, in July 2025, melanoma experts and patient advocates pressed the agency to reconsider and conduct another review, with FDA receiving several letters from experts from Roswell Park Cancer Institute, Banner MD Anderson, and Moffitt Cancer Center. Ultimately, Congress, the White House, and HHS were drawn into the dance. According to a report from the Wall Street Journal, the White House pushed FDA to get Replimune its third review after the company “met with the White House in early May, arguing the rejections didn’t match up with the Trump administration’s desire to help terminally ill patients.” In this episode of The Cancer Letter Podcast, Paul Goldberg, editor and publisher with The Cancer Letter, and Jacquelyn Cobb, associate editor, discuss the implications of this news on the future of the agency and drug development.  “Now, there is no way in the heck that anyone can predict what FDA is going to do and why and how,” Paul said. “In the past, you could sort of figure it out. You know, ‘Oh, you have no chance here.’ In this case, I don't know. I mean, I'm in the fog. “Prepare for more of these because what we've seen is FDA not acting the way FDA ever has. FDA just being something else. I don't know what that means. I don't think anybody else knows what that means… “I've never been more puzzled writing a story about FDA, and I think this is just the beginning.” This episode is sponsored by the University of Kentucky Markey Cancer Center. Learn more at ukhealthcare.com/markey. Stories mentioned in this podcast include: New directors Herbst and Gius chart a future built on AI, collaboration, and rural access FDA grants Replimune's RP1 an accelerated approval on third submission after 10:3 vote from advisory committee Consumers are increasingly accessing U.S. News rankings of cancer hospitals via AI chatbots 2026 report shows no change in the top-five lineup Marketing hope before surgery: Does the new Keytruda commercial tell patients the whole story?  Senate leaders introduce revised, bipartisan stopgap bill that would ban OMB from finalizing rule that would politicize science  Federal judge declines to block Medicaid work requirements  HRSA redrafts 340B rebate pilot program after courts block the original version  A transcript of this podcast is available: https://cancerletter.com/podcastc/20260812-replimune/

New pressures notwithstanding, being a cancer center director is still a dream job, two of the nation’s newest cancer center directors say. In their first weeks in the top jobs at their institutions, Dartmouth’s Roy Herbst and the University of Cincinnati’s David Gius told us how the director’s job comes with an opportunity to imbue the center’s programs with a new energy and explore new directions in science. Herbst and Gius appeared together on The Directors, a monthly podcast series which focuses on the problems that keep directors of cancer centers up at night.  Both Herbst and Gius acknowledge the mounting funding pressure due to tighter federal research funding and rising costs of doing research. They argue that the next generation of advances will come from combining academic science and industry partnerships to bring cutting-edge treatments to more people—including those in rural and underserved communities.  “I understand my responsibility. I'm busier than I've ever been before, but this is what I've been looking for my entire career. It's a capstone for me, and I'm really excited to be here,” said Herbst, who at the recording of this podcast was in his third week as director of Dartmouth Cancer Center, an NCI-designated Comprehensive Cancer Center. Gius was in his fourth week as director of the University of Cincinnati Cancer Center at the recording of this podcast. “Getting this job is something I've always aspired to. I agree, it's something to cap your career. There's a lot of responsibility, and it's my fourth week, so there's a lot to do,” Gius said. A transcript is available at: https://cancerletter.com/podcastc/20260807_1/