BioCentury
ARTICLE | Regulation

Swayed by lack of alternatives, ODAC votes to retain Tecentriq accelerated approval for triple-negative breast cancer

Given lack of confirmatory data, the outcome could lower confidence in accelerated approval pathway

April 28, 2021 1:55 AM UTC

The lack of substantially better alternative therapies, rather than compelling clinical data, seems to have prompted an FDA advisory committee to vote 7-2 Tuesday against withdrawing accelerated approval for Genentech’s Tecentriq with nab-paclitaxel to treat PD-L1-positive triple-negative breast cancer.

FDA granted accelerated approval to Tecentriq atezolizumab from the Genentech Inc. unit of Roche (SIX:ROG; OTCQX:RHHBY) in March 2019 for TNBC based on data from the IMpassion130 trial. The data showed that patients who received the drug experienced a median 7.4 months of progression-free survival (PFS) compared with 4.8 months for those who received nab-paclitaxel plus placebo. ...