The Cancer Letter

The Cancer Letter
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The Cancer Letter, an independent weekly news publication, has been the leading source for information on the issues that shape oncology since 1973. With a dedicated audience of oncology’s leaders, The Cancer Letter stays on top of breaking news and advances in oncology, providing authoritative, award-winning coverage of the development of cancer therapies, drug regulation, legislation, cancer research funding, health care finance, and public health. This weekly podcast features interviews, discussions, and more to dig deep into the issues that shape oncology.

  1. 6d ago

    Brian Wolpin celebrates FDA approval of daraxonrasib in pancreatic cancer as the future of the field

    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/

    Brian Wolpin celebrates FDA approval of daraxonrasib in pancreatic cancer as the future of the field

  2. Aug 26

    Trump’s tariffs on generic drugs are “another wrinkle in an already unstable system”

    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/

    Trump’s tariffs on generic drugs are “another wrinkle in an already unstable system”

  3. Aug 19

    Raja Flores says oncology is loose with staging jargon, and now “it’s confusing my patients.”

    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/

    Raja Flores says oncology is loose with staging jargon, and now “it’s confusing my patients.”

  4. Aug 12

    What happened at FDA? Replimune approval raises questions

    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/

    What happened at FDA? Replimune approval raises questions

  5. Aug 7

    The Directors: New directors Herbst and Gius chart a future built on AI, collaboration, and rural access

    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/

    The Directors: New directors Herbst and Gius chart a future built on AI, collaboration, and rural access

  6. Aug 5

    Pour a Scotch, we’re talking clinical trials and prediction markets

    In last week’s issue of The Cancer Letter, the cover story featured coverage of Kalshi, an online prediction market exchange, launching a pilot program in which one can place bets on both outcomes of trials and FDA decisions.  In this episode of The Cancer Letter Podcast, Paul Goldberg, editor and publisher with The Cancer Letter, and Jacquelyn Cobb, associate editor, discuss the Kalshi’s entrance into betting on clinical trials and drug development.  “This is worth reading. I mean, this is, for those who still drink, definitely an excellent accompaniment to a Scotch. It will go well with Scotch,” Paul said. “Even though I prefer vodka, this will go with Scotch.” A big chunk of the story about Kalshi was made up of the answers to a three-question survey that The Cancer Letter administered to members of the oncology community.  In the podcast, Jacquelyn and Paul recalled one answer they found particularly enjoyable. “Prediction markets are another opportunity to violate the law, but, if used correctly, there should not be a problem. Overall, I don’t think this is problematic for society, but certainly creates another opportunity for my colleagues to lose money and go to jail,” Mark Ratain, director of the Center for Personalized Therapeutics, the Leon O. Jacobson Professor of Medicine, chief hospital pharmacologist at University of Chicago Medicine, said to The Cancer Letter in last week’s cover story.  This episode is sponsored by City of Hope. Learn more at www.cityofhope.org. Stories mentioned in this podcast include: Prediction markets now allow betting on clinical trial results, FDA decisions It’s a high-risk bet: Insider trading, equipoise, integrity of research, public trust are at stake  Trump plans a 200% tariff on imported generic drugs by 2029, raising fears of cancer drug shortages Retraction is not refutation: Why chrono-immunotherapy still deserves scientific investigation  Joseph F. Fraumeni Jr., inventor of molecular epidemiology, was a “gentle giant” who “bet on the good people” Chanock and Brawley reflect on their illustrious mentor  FDA’s OCE publishes three final guidances to increase clinical trial enrollment A transcript of this podcast is available: https://cancerletter.com/podcastc/20260805-predictionmarkets/

    Pour a Scotch, we’re talking clinical trials and prediction markets

  7. Jul 29

    Hegseth offers soldiers testosterone and FDA loosens safety warnings. Is the science there?

    Last week, the Pentagon posted a video on X announcing they will be mandating testosterone screening for troops in the military aged 30 and above. If they test low, they will be offered voluntary testosterone replacement therapy. At the same time, FDA has announced it will be loosening safety warnings on the labels for testosterone replacement therapy. The primary evidence base to guide that decision is cited as the 2023 TRAVERSE trial. However, screening experts, endocrine specialists, and even the first author of the TRAVERSE study said that this trial was not designed to study the effectiveness of long-term TRT use. It was designed to look primarily at cardiovascular risk. The big issue isn’t TRT use itself, it is the overinterpretation of evidence to broaden the use of TRT therapy in people who may not need it.  “The risks of over testing, over treatment, over diagnosis—cannot be overstated,” said Claire Marie Porter, a reporter with The Cancer Letter.  Should one screen an asymptomatic population for a condition that no major medical society recommends screening for? That's where many experts draw the line.  In this episode of The Cancer Letter Podcast, Claire and Jacquelyn Cobb, associate editor of The Cancer Letter, discuss the implications of overuse of TRT, in oncology and otherwise. “Anxiety is not the only consequence of overscreening,” Jacquelyn said. “There are actually potential health outcomes that could come from over screening. And I think that's sort of the missing link, that there could be harm introduced that was not necessary.” Some of those harms could include fertility decrease, prostate changes, hormone suppression, and more.  “If you are on testosterone replacement therapy for long periods of time, your pituitary glands will stop making it,” Claire said. “Increased PSA testing will likely happen—the Endocrine Society recommends it—which means more biopsies, more false positives, more anxiety, and just decades of treatment beginning in your thirties.” TRT has an accepted role for men with diagnosed hypogonadism, but population-wide testing is a very different policy, experts say.  “Many sources were like, this is basically an uncharted, natural, human experiment,” Claire said. This episode is sponsored by the American Society of Clinical Oncology. Learn more at asco.org/ascoaction. Stories mentioned in this podcast include: Cancer hospitals brace for impact, as CMS moves to slash 340B payments by 33% Hegseth orders testosterone testing for troops as FDA moves to loosen TRT prostate cancer warnings The Susan Wojcicki Foundation pushes for rethinking of strategies for early lung cancer detection Gary Morrow, a pioneer in supportive oncology, dies of prostate cancer complications at 82 A transcript of this podcast is available: https://cancerletter.com/podcastc/20260729-trt/

    Hegseth offers soldiers testosterone and FDA loosens safety warnings. Is the science there?

  8. Jul 22

    How will FDA regulate psychedelics?

    FDA has been taking a look at psychedelics as a potential treatment for psychiatric and substance abuse disorders, recently publishing a final guidance for drug sponsors conducting clinical trials of psychedelics, including psilocybin, LSD, and MDMA.  “This is of interest to psycho-oncologists that have been looking into this question for at least two decades around cancer-related anxiety, depression, and PTSD,” said Sara Willa Ernst, a reporter with The Cancer Letter. “Could psilocybin specifically be a treatment to help cancer patients and cancer survivors deal with psychological distress that comes from a cancer diagnosis?” However, regulatory challenges emerge when FDA is tasked with evaluating a treatment that may (or may not) rely on both a drug and a psychotherapy component to improve outcomes. In this episode of The Cancer Letter Podcast, Sara and Paul Goldberg, editor and publisher of The Cancer Letter, discuss the tricky regulatory landscape facing psycho-oncologists.  “FDA does not regulate psychotherapy,” Sara said. “I think a lot of the sources, the clinical trialists I talked to said, admittedly, ‘This is kind of a weird space for FDA to approve or not approve.’” But psycho-oncology experts with experience administering psychedelic therapy are almost uniformly convinced that the psychotherapy component is critical to the treatment’s efficacy. Most of Sara’s sources ended up “echoing the same thing—that the psychotherapy component is very crucial,” she said.  While FDA is staying in its lane and remaining agnostic to a question for which there is not yet satisfying data, Sara said her sources are concerned about what that might mean for the development of the field. “FDA has opened the door—at least in the final guidance—to applications that kind of de-emphasize the psychotherapy aspect. So, that might be a whole lot cheaper for a pharmaceutical company that is trying to bring a drug to market to go in that direction as opposed to the real hefty lift of a factorial design trial [to demonstrate the role of psychotherapy],” Sara said. “A lot of methodologists are having a lot of fun deciphering this,” Paul said. “How do you go forward with this? Could be very interesting.” This episode is sponsored by the University of Kentucky Markey Cancer Center. Learn more at ukhealthcare.com/markey. Stories mentioned in this podcast include: The Directors: Two leaders in data science have a warp speed vision for AI, with cancer clinical trials leading the way Knudsen and Thoelke FDA final guidance on psychedelics opens the door to psycho-oncology research OMB proposal to sideline peer review sparks widespread opposition Cancer progress is not reaching everyone. Native Nations must be part of the solution. The future of oncology: Early-career scientists need mentorship and a new academic model A transcript of this podcast is available: cancerletter.com/podcastc/20260722-psychedelics/

    How will FDA regulate psychedelics?
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The Cancer Letter, an independent weekly news publication, has been the leading source for information on the issues that shape oncology since 1973. With a dedicated audience of oncology’s leaders, The Cancer Letter stays on top of breaking news and advances in oncology, providing authoritative, award-winning coverage of the development of cancer therapies, drug regulation, legislation, cancer research funding, health care finance, and public health. This weekly podcast features interviews, discussions, and more to dig deep into the issues that shape oncology.

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  • Creator
    The Cancer Letter
  • Years Active
    2025 - 2026
  • Episodes
    106
  • Rating
    Clean
  • Copyright
    © The Cancer Letter
  • Show Website
    The Cancer Letter

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