FDA updates approval label of Keytruda from accelerated to full approval in urothelial carcinoma (bladder cancer).- Merck Inc

Previously, Keytruda was indicated for the treatment of patients with locally advanced or mUC who were not eligible for cisplatin-containing chemotherapy and whose tumors expressed PD-L1 (Combined Positive Score [CPS] of at least 10), as determined by an FDA-approved test, or in patients who were not eligible for any platinum-containing chemotherapy regardless of PD-L1 status. This indication was approved under accelerated approval based on tumor response rate and duration of response. Continued approval was contingent upon verification and description of clinical benefit in confirmatory trials.

The subsequent Phase III trial KEYNOTE-361, evaluating Keytruda as monotherapy and in combination with chemotherapy for the first-line treatment of patients with advanced or mUC who were eligible for platinum-containing chemotherapy, did not meet its pre-specified dual primary endpoints of overall survival or progression-free survival, compared with standard of care chemotherapy.

This label update follows the FDA’s Oncologic Drugs Advisory Committee (ODAC) meetings held earlier this year as part of an industry-wide evaluation of indications based on accelerated approvals that have not met their post-marketing requirements.