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.
Merck & Co., Inc.and Genentech, Inc. are both at risk of losing their first line accelerated approvals for their respective PD-1/L1 inhibitors in bladder cancer but each sponsor may have one key way to buy themselves at bit more time when their immunotherapies – Keytruda and Tecentriq – come up for votes 28 April at the US Food and Drug Administration’s Oncologic Drugs Advisory Committee.
Both drugs are indicated for the first-line treatment of patients with locally advanced or metastatic urothelial carcinoma who are not...
