Two Years In US Accelerated Approval Withdrawals
Twenty accelerated approval indications have been voluntarily withdrawn by sponsors since December 2020, most coming as a result of the FDA cancer office’s push to rid labeling of ‘dangling’ and ‘delinquent’ indications that lack confirmation of clinical benefit.
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Ideally, the studies would be underway at the time of approval, as the US FDA’s new authority allows, but Office of Therapeutic Products Director Nicole Verdun sys there will be exceptions.
Supplemental Filings: FDA-CMS Collaboration, Beyfortus Approved For Pediatric RSV, Gavreto Loses An Indication, Sanders' Biosimilar Auto-Interchangeability Bill
CDER Director Cavazzoni has her description of CMS’ mandate corrected, the FDA approves AstraZeneca/Sanofi's nirsevimab but requires safety studies on RSV variants, Genentech and Blueprint Medicines withdraw Gavreto's medullary thyroid cancer claim due to confirmatory trial feasibility issues, and Bernie Sanders goes bold on biosimilars.
The EMBARK trial’s availability to more patients likely contributed to the much quicker enrollment than confirmatory trials for Exondys 51, Vyondys 53 and Amondys 45, which also saw enrollment targets and eligibility ages change over the years.