Bladder Cancer Accelerated Approvals: Merck, Genentech PD-1/L1 Inhibitors Prevail At US FDA Panel, But For Different Reasons
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.
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US FDA showed some regulatory flexibility by relying on longer-term follow-up from Merck’s original single-arm trial, rather than additional confirmatory studies, to retain the first-line claim, but it narrowed the target population to those with the greatest unmet need; Keytruda indication was one of six 'dangling' accelerated approvals re-examined by Oncologic Drugs Advisory Committee in April.
Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.
US FDA’s Accelerated Approval process has always been a deceptively simple idea. After a three-day public review of ‘dangling’ applications, the underlying complexity remains.