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Bladder Cancer Accelerated Approvals: Merck, Genentech PD-1/L1 Inhibitors Prevail At US FDA Panel, But For Different Reasons

 
• By Sarah Karlin-Smith

Merck’s path forward is less clear than Genentech’s after US FDA’s Oncologic Drugs Advisory Committee says Keytruda and Tecentriq should hold on to their accelerated approvals for locally advanced or metastatic urothelial carcinoma patients who are not eligible for cisplatin-containing chemotherapy. FDA has to figure out a confirmatory study for Merck and weigh potentially limiting indication. 

two different, diverging roads
Keytruda and Tecentriq took different paths to positive ODAC votes • Source: Alamy

Two different US Food and Drug Administration panels voted in favor of keeping Merck & Co., Inc. and Genentech, Inc. ’s accelerated approvals for their respective PD-1/L1 inhibitors in bladder cancer, but the reasoning for the two 28 April votes was quite different despite the similarity of the immunotherapies and the indications.

For Merck’s Keytruda (pembrolizumab) the Oncologic Drugs Advisory Committee members were persuaded by the unmet need of a fraction of patients subject to the initial indication who wouldn’t be eligible...

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