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Accelerated Approval: US FDA Review Of Expedited Program Could Bring More Withdrawals

 
• By Sue Sutter

Oncology Center of Excellence’s ‘industry-wide evaluation’ of accelerated approvals leads to removal of indications for two PD-1/L-1 inhibitors, AstraZeneca’s Imfinzi and Bristol-Myers Squibb’s Opdivo, both of which had failed confirmatory trials.

Boat deck
Is the FDA's Oncology Center of Excellence trying to clear the deck of accelerated approval indications with failed confirmatory trials? • Source: Shutterstock

The recent withdrawal of accelerated approval indications for two cancer immunotherapies is part of a broader US Food and Drug Evaluation review of the expedited pathway and could portend more oncology drug and indication removals for failure to confirm clinical benefit.

On 22 February, AstraZeneca PLC announced the withdrawal of its PD-L1 inhibitor Imfinzi (durvalumab) for use in previously treated...

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Post-Approval, Real-Time Monitoring Will Help Approval Standards, US FDA’s Makary Says

 
• By Sue Sutter

The FDA will use electronic health records to “get eyes” on drugs immediately after approval, Commissioner Martin Makary told the DIA 2025 Global Annual Meeting. He also wants to reduce development time with better communication and new approval pathways.

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• By Sarah Karlin-Smith and Derrick Gingery

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