FDA Advisory Committee votes in favour of maintaining accelerated approval of Genentech’s Tecentriq for PD-L1 positive, metastatic triple negative breast cancer

Genentech

27 April 2021 - Genentech today announced the U.S. FDA Oncologic Drugs Advisory Committee voted 7 to 2 in favour of maintaining accelerated approval of Tecentriq (atezolizumab) in combination with chemotherapy (Abraxane, albumin-bound paclitaxel; nab-paclitaxel) for the treatment of adults with unresectable locally advanced or metastatic triple negative breast cancer whose tumours express PD-L1, as determined by an FDA approved test. 

Today’s Oncologic Drugs Advisory Committee meeting is part of an industry-wide review of accelerated approvals with confirmatory trials that have not met their primary outcome(s) and have yet to gain regular approvals. The advisory committee provides the FDA with independent opinions and recommendations from outside medical experts, though the recommendations are not binding. 

The FDA has not announced when it will make its final decision for Tecentriq in this indication.

Read Genentech press release

Michael Wonder

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Michael Wonder