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An advisory panel recommended the FDA not revoke the accelerated approval for atezolizumab (Tecentriq) in combination with nab-paclitaxel (Abraxane) for treating metastatic, PD-L1-positive triple-negative breast cancer (TNBC).
In a 7-2 vote, the Oncologic Drugs Advisory Committee (ODAC) affirmed the accelerated approval, with members clearly conflicted over the decision. This was a difficult decision in a very difficult disease to treat, said Harold Burstein, MD, PhD, of the Dana-Farber Cancer Institute in Boston, who voted yes on the proposition. I have spent decades caring for these patients, and we all wish we had fundamentally better options.
FDA initially granted atezolizumab, a PD-L1 immune checkpoint inhibitor, accelerated approval in 2019 in combination with nab-paclitaxel for patients with untreated metastatic or locally advanced unresectable TNBC whose tumors express PD-L1, based on findings from the IMpassion130 trial, which showed a significant