Benzinga | Apr 29, 2021 11:47AM EDT

Oncologic Drugs Adcomm Backs Merck's Keytruda, Roche's Tecentriq Accelerated Approvals In Bladder Cancer

* The FDA's Oncologic Drugs Advisory Committee voted 5-3 in favor of keeping Merck & Co's (NYSE: MRK) Keytruda (pembrolizumab) accelerated approval alive as a first-line bladder cancer treatment, even after a Merck confirmatory trial failed.

* While the confirmatory trial did not show a benefit for Keytruda as a first-line treatment, much of the discussion centered on these subgroups of patients who might have no treatment options without Keytruda.

* The current nod allows Keytruda to be used in previously untreated patients who are cisplatin-ineligible and carboplatin-ineligible. It's also approved for those who aren't eligible for any platinum chemo, regardless of their PD-L1 status.

* Also, ODAC voted 10-1 in favor of keeping Roche Holdings AG's (OTC:RHHBY) Tecentriq (atezolizumab) as a first-line treatment of cisplatin-ineligible patients with advanced/metastatic bladder cancer pending final overall survival results from a confirmatory trial, known as IMvigor130.

* On Tuesday, the committee members voted 7-2 to keep alive the accelerated approval for Tecentriq plus Abraxane (nab-paclitaxel) in metastatic triple-negative breast cancer while additional confirmatory trials are ongoing.

* FDA Briefing Documents here.

* Price Action: MRK shares are down 5.15% at $73.12, and RHHBY is down 0.58% at $41.26 on the last check Thursday.