FDA’s Pazdur: Accelerated Approval Is ‘Under Attack,' Supporters Can’t Afford To Remain Silent
US FDA’s Oncology Center of Excellence Director and the National Institutes of Health National Cancer Institute Director defended the agency’s accelerated approval pathway, saying critics are missing the benefits reaped by many cancer patients. Pazdur worries pathway is at risk, unless champions work to counter critics.
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HHS Inspector General’s timeline means Congress won’t have findings to use during upcoming user fee renewal debate; ‘review’ is not an ‘investigation’ which could come with potentially more damning legal consequences for the agency.
BMS’ histone deacetylase inhibitor is the first oncology drug outside the PD-1/L1 class to lose an indication under US FDA’s recent review of ‘dangling’ accelerated approvals. Claim for second-line peripheral T-cell lymphoma was withdrawn because first-line study failed to meet its progression-free survival endpoint.
FDA’s Pazdur Blames Trial Design Errors For Some PD-1/L1 Failures, Foreshadows Potential Agency Leniency
US FDA Oncology Center of Excellence Director Rick Pazdur says PD-1/L1 drugs are very similar and hypothesizes that when competitors show differing results in the same indication it's more about trial design than the drug. FDA oncology experts also weighed in on regulatory clearance of Chinese-developed checkpoint inhibitors and trial endpoints that have come under outside scrutiny.