Bladder Cancer Accelerated Approvals: Merck’s Keytruda and Genentech’s Tecentriq Each May Have One Last Lifeline
US FDA will ask advisory committee whether data from the trial supporting full approval of Merck’s Keytruda for second-line setting can be used to confirm clinical benefits for earlier setting of patients with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin-containing chemotherapy following a failed confirmatory study. Genentech’s Tecentriq is also at risk of losing its accelerated approval in that space but it could buy some time as its confirmatory study is not yet complete. New competitor entrant since accelerated approvals also lessens degree of unmet need.
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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.
Although US FDA panelists said that ideally a new confirmatory trial would be conducted in the same triple-negative breast cancer population, they acknowledged the sponsor’s feasibility concerns and suggested instead that the IMpassion132 trial, expected to report in 2023, might suffice.
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.