The Cancer Letter

The Cancer Letter

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

    Cancer breakthroughs hit the clinic, cancer policy hits the ballot box

    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.

    Cancer breakthroughs hit the clinic, cancer policy hits the ballot box
  2. Oct 21

    As USPSTF falters and FDA ignores clinical benefit, “the idea that screening is always good is probably gaining traction right now”

    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 USPSTF falters and FDA ignores clinical benefit, “the idea that screening is always good is probably gaining traction right now”
  3. Oct 16

    The Directors: VCU’s Baskin and UNC’s Ferris weigh oncology’s looming dilemma—MCDs

    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/

    The Directors: VCU’s Baskin and UNC’s Ferris weigh oncology’s looming dilemma—MCDs
  4. Oct 14

    As FDA sidesteps the question of Galleri’s clinical benefit, NCI’s Letai has “some concerns”

    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/

    As FDA sidesteps the question of Galleri’s clinical benefit, NCI’s Letai has “some concerns”
  5. Oct 7

    Anthony Letai reflects on Year One as NCI Director: “The NCI is in business”

    “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/

    Anthony Letai reflects on Year One as NCI Director: “The NCI is in business”
  6. Sep 30

    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
  7. 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
  8. 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?

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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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