Genentech’s Hopes For Keeping Tecentriq Breast Cancer Claim May Rest With Trial In Early Disease Recurrence

23 Apr 2021

Even though IMpassion132 is enrolling a different population and has a different chemotherapy backbone, it could confirm atezolizumab’s benefit for patients with advanced triple-negative breast cancer whose tumors express PD-L1, agency says ahead of advisory committee meeting on accelerated approval indications with failed confirmatory trials.

Breast cancer cell — Tecentriq's accelerated approval in triple-negative breast cancer is on the line. • Source: Alamy

An ongoing Phase III trial of Genentech, Inc. 's Tecentriq (atezolizumab) in patients who experienced early recurrence of triple-negative breast cancer after prior therapy could provide a pathway to confirming the PD-L1 inhibitor’s benefit in first-line TNBC, a current accelerated approval indication facing the threat of withdrawal.

On 27 April, the Food and Drug Administration’s Oncologic Drugs Advisory Committee will kick off three days of meetings on...