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

    The Galleri MCD vote: What FDA asked its advisors to ignore

    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

    The Galleri MCD vote: What FDA asked its advisors to ignore

  2. Sep 25

    The Directors: Two Gulf Coast cancer center directors on why NCI designation matters—and why they want it

    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/

    The Directors: Two Gulf Coast cancer center directors on why NCI designation matters—and why they want it

  3. Sep 23

    36 months to live, 29 months to wait. Why is Congress withholding lifesaving benefits from breast cancer patients?

    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/

    36 months to live, 29 months to wait. Why is Congress withholding lifesaving benefits from breast cancer patients?

  4. Sep 16

    9/11, mRNA, musical chairs—and an assassination attempt

    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.” 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/

    9/11, mRNA, musical chairs—and an assassination attempt

  5. Sep 9

    As daraxonrasib hits the clinic, Frank McCormick says RAS is bigger than pancreatic cancer

    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/

    As daraxonrasib hits the clinic, Frank McCormick says RAS is bigger than pancreatic cancer

  6. Sep 2

    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

  7. 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”

  8. 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.”
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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
    111
  • Rating
    Clean
  • Copyright
    © The Cancer Letter
  • Show Website
    The Cancer Letter

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