The FDA Oncologic Drugs Advisory Committee (ODAC) voted 7-2 in favor of maintaining the accelerated approval of atezolizumab in combination with chemotherapy for the treatment of unresectable locally advanced or metastatic PD-L1 positive triple negative breast cancer, according to a press release.
This decision comes as part of an industry-wide review of accelerated approvals with confirmatory trials that have not met their primary endpoints.
The committee’s decision is not binding and the FDA has not announced when they will make a decision for atezolizumab, or the other drugs under review.
The FDA granted accelerated approval, which allows for conditional approval of drugs that fill an unmet need while further study is being done, to this treatment in March 2019. That approval was based on improved progression free survival with atezolizumab plus chemotherapy in the IMpassion 130 study.
The confirmatory trial, IMpassion131 did not meet its primary endpoint of improved PFS for the first-line treatment of patients with PD-L1 positive metastatic TNBC.