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

 
• By Sue Sutter

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 the drug’s accelerated approval, they acknowledged such a study...

Consequently, the majority vote appears to open the door to use of an ongoing Phase III study in patients who experienced early disease recurrence as a potential confirmatory trial. Results...

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