Roche’s cancer immunotherapy Tecentriq (atezolizumab), a PD-L1 inhibitor, scored its fifth Food and Drug Administration approval on Friday, for advanced triple-negative breast cancer, but the fifth was a first: Before this decision, no immunotherapies had been approved for any form of breast cancer. The approval, as is typical, was narrow: for locally advanced or metastatic triple-negative breast cancer expressing PD-L1, the molecule that locks onto PD-1 receptors on the surface of T cells. (Triple-negative means the tumor cells do not have estrogen receptors, progesterone receptors, or HER2, all of which fuel uncontrolled cell proliferation but can be blocked with drugs such as Herceptin.) Unlock this article by subscribing to STAT Plus and enjoy your first 30 days free! STAT Plus is STAT's premium subscription service for in-depth biotech, pharma, policy, and life science coverage and analysis. Our award-winning team covers news on Wall Street, policy developments in Washington, early science breakthroughs and clinical trial results, and health care disruption in Silicon Valley and beyond.
The US Food and Drug Administration (FDA) has granted narrow approval for Roche’s cancer drug Tecentriq, a first for any kind of breast cancer immunotherapy. Tecentriq, aimed at local advanced or metastatic triple-negative breast cancer, binds with the PD-L1 molecule and prevents it from stopping T-cells attacking tumours. There is not enough data from the ongoing IMpassion 130 clinical trial to determine whether Tecentriq can extend life expectancy in triple negative breast cancer patients beyond the median 25 months, and further FDA approval could depend on final survival analysis data due to be released later this year.