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 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 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.