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Keeping Track: Enhertu, Nubeqa Grow With RTOR; Interchangeable Cimerli And Another Nuplazid CRL

 
• By Bridget Silverman

The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker

Keeping Track Feature image

The FDA topped off last week with two approvals under its popular Real-Time Oncology Review (RTOR) program, granting new indications to AstraZeneca PLC/Daiichi Sankyo Co., Ltd.’s Enhertu in HER2-low breast cancer and Bayer AG/Orion Corporation’s Nubeqa in hormone-sensitive prostate cancer.

While both approvals came in advance of the user fee goal date, the two-month review of the new Enhertu indication harkens back to the surprising early days of the RTOR program

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• By Bridget Silverman

The lack of a formal analysis of efficacy in castration-resistant prostate cancer patients without HRR mutations doomed Pfizer’s Talzenna at the US FDA's Oncologic Drugs Advisory Committee, as FDA oncology chief Richard Pazdur says chance cannot be ruled out.

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More from North America

STARGLO Dulled: Genentech’s Columvi Data Not Generalizable To US Patients, FDA Panel Says

 
• By Sue Sutter

The glofitamab trial results are not generalizable due to the small number of enrolled US lymphoma patients and adverse results across multiple endpoints for patients from non-Asian regions, the Oncologic Drugs Advisory Committee said.

Legal, Process Problems May Plague New US FDA COVID-19 Vaccine Policy

 
• By Sarah Karlin-Smith

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• By Derrick Gingery

The Health and Human Services secretary told a Senate appropriations subcommittee that placebo-controlled trials may not be necessary to ensure vaccine safety as the FDA released a framework requiring them for COVID-19 vaccines.