Genentech’s Tecentriq Should Keep Its Accelerated Approval In Breast Cancer For Now, ODAC Says

29 Apr 2021

Although US FDA panelists said that ideally a new confirmatory trial would be conducted in the same triple-negative breast cancer population, they acknowledged the sponsor’s feasibility concerns and suggested instead that the IMpassion132 trial, expected to report in 2023, might suffice.

Batter up — Genentech was the first sponsor to bat at the 3-day ODAC meeting on accelerated approval indications. • Source: Alamy

The US Food and Drug Administration should maintain the accelerated approval indication for Genentech, Inc.’s PD-L1 inhibitor Tecentriq (atezolizumab) in triple-negative breast cancer pending additional trials to confirm clinical benefit, the Oncologic Drugs Advisory Committee said 27 April.

Although some panelists said a new confirmatory trial should mimic the population of patients in the IMpassion130 trial, which supported...