With Anthony Letai’s appointment, NCI is now under new leadership—just in time for a shut down скачать в хорошем качестве

With Anthony Letai’s appointment, NCI is now under new leadership—just in time for a shut down

With little fan fare, Anthony Letai, a highly respected physician-scientist, was sworn in as the 18th director of the National Cancer Institute on Sept. 29. Then, two days later, on Oct. 1, the government shut down. The news of Letai’s apparent appointment was broken last week in the media, with no word from the White House. Although HHS has published a press release announcing Letai’s appointment, the White House is still silent on the matter. Meanwhile, Trump’s FDA initiated an unusual regulatory pathway for leucovorin—asking the drug sponsor to reinstate a 25-year-old drug application—in order to begin the process of approving the drug for autism. This week on The Cancer Letter Podcast, Paul Goldberg, editor and publisher of The Cancer Letter, and Jacquelyn Cobb, associate editor, discuss the oncology community’s enthusiastic support for Letai’s appointment, the government shut down, and the strange regulatory future of leucovorin. “Here's the issue,” Paul said. “Leucovorin is a branded drug up through about 1997. By 1997, the company asks to just let it go to the generics. ‘The heck with this thing.’ Then, by 1999—GSK is the sponsor—GSK just withdraws from the whole thing, which makes perfect sense. That's what pioneer companies do, because who wants to be updating the label on something you're not selling? Who wants to be responsible for that? So, that's just typical behavior. “So, a quarter of a century ago. Now, fast forward to now and 26 years later, really, and there's this sort of a political push, not necessarily scientific, but maybe a little so, to get this thing approved for autism, for a form of autism. So, the only reason to get that approval is so you can start promoting it. “So, really, probably for the first time in the history of FDA and therefore likely for the first time in human history, the company was allowed, or in this case, really probably prevailed upon, to renew, revive, its NDA, and then seek a supplemental NDA for this indication.” Stories mentioned in this podcast include: Anthony G. Letai to be named NCI director. The Dana-Farber and Harvard physician-scientist is an inspired choice, colleagues say Trump’s FDA invents an unusual regulatory pathway to approve leucovorin for autism. Experts call the move “extremely premature” Population-based cancer surveillance is a national treasure at risk, by Eric B. Durbin, Karen L. Knight, Betsy Kohler, and Sarah Nash Ci4CC’s 24th Symposium & Workshop set to focus on precision oncology powered by data intelligence, by Stephen D. Nimer Earlier diagnosis, better outcomes: Telemedicine has found a home in oncology, by Hardeep Phull Championing nurse wellbeing as a strategic priority, by Kim Slusser A transcript of this podcast is available: https://cancerletter.com/podcastc/202...