FDA panel votes to keep accelerated approval of Roche's Tecentriq combo in TNBC

An FDA advisory committee (AdCom) convening over several days this week to review accelerated approvals for checkpoint inhibitors voted 7 to 2 on Tuesday in favour of keeping the one granted to Roche's Tecentriq (atezolizumab) in 2019 for triple-negative breast cancer (TNBC). Levi Garraway, head global product development at Roche, called the decision "significant" given that patients with TNBC "have few treatment options."

The 2019 accelerated approval was for Tecentriq to be used together with Bristol Myers Squibb's Abraxane (nab-paclitaxel) in patients with unresectable, locally advanced or metastatic TNBC whose tumours express PD-L1. The FDA's decision at the time was based on "highly encouraging" progression-free survival (PFS) data from the Phase III IMpassion130 trial. However, continued approval hinged on IMpassion131, another late-stage study in which the combination Tecentriq plus chemotherapy ultimately failed to show a survival benefit in PD-L1-positive patients being treated for metastatic TNBC in the first-line setting.

The FDA AdCom meeting, which runs through to April 29, is part of an industry-wide reevaluation of accelerated approvals with confirmatory trials that have not met their primary endpoints and have yet to gain full regular approvals (for additional analysis, see ViewPoints: All eyes on FDA accelerated approval review). Roche noted that the FDA has not said when it will make its final decision for Tecentriq in the TNBC indication, but "as the clinically meaningful benefit demonstrated in the IMpassion130 study remains, [we] looks forward to continuing to work with the FDA to determine next steps with regard to Tecentriq in this indication."

On Wednesday, the AdCom meets again to assess Tecentriq's 2017 accelerated approval for patients with locally advanced or metastatic urothelial carcinoma who are ineligible for cisplatin-containing chemotherapy. In addition, the FDA panel will look at updates on Merck & Co.'s Keytruda (pembrolizumab) for the same urothelial carcinoma indication. By the time the AdCom wraps up this Thursday, panel members will also have reviewed Keytruda accelerated approvals in gastric cancer and hepatocellular carcinoma, and Bristol Myers Squibb's Opdivo (nivolumab) in liver cancer as well.

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