Keeping Track: US FDA Acts On 5 Novel Drugs: Approval For Fotivda, Pepaxto, Azstarys; CRLs For Defencath and Oral Paclitaxel
Executive Summary
The latest drug development news and highlights from the Pink Sheet US FDA Performance Tracker
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Accelerated Approval: US FDA Panel To Reconsider Six Indications For Checkpoint Inhibitors
Oncologic Drugs Advisory Committee will meet for three days in April to consider whether indications for Tecentriq, Keytruda and Opdivo should remain on label despite failure to confirm clinical benefit; review is part of the Oncology Center of Excellence’s ‘industry-wide evaluation’ of accelerated approvals, which has led to withdrawals of four other PD-1/L-1 inhibitor claims.
Persistence Pays Off With US Approval Of Aveo’s Fotivda In RCC
The approval marks the first commercial launch for Aveo in the US, but tivozanib has shown modest efficacy in cancer and the approval is relegated to later lines.