Genentech Provides Update on Tecentriq U.S. Indication for PD-L1-Positive, Metastatic Triple-Negative Breast Cancer

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the company has made the decision to voluntarily withdraw the U.S. accelerated approval for Tecentriq (atezolizumab) in combination with chemotherapy (Abraxane, albumin-bound paclitaxel; nab-paclitaxel) for the treatment of adults with unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) whose tumors express PD-L1, as determined by a U.S. Food and Drug Administration (FDA)-approved test. Genentech made this decision following consultation with the FDA based on the agency’s assessment of the current mTNBC treatment landscape and in accordance with the requirements of the accelerated approval program. This decision only impacts the mTNBC indication in the U.S. It does not affect other approved indications for Tecentriq in the U.S. and outside the U.S., including mTNBC. This is not related to any changes in either the efficacy or safety associated with Tecentriq.

“TNBC remains the most challenging type of breast cancer to treat, which makes the decision to withdraw so difficult for us, as patients have had this medicine as an important option for more than two years,” said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. “We appreciate the opportunity to have been able to help people with mTNBC in the U.S. with Tecentriq through the accelerated approval process, which has brought many significant and novel therapies to patients. We remain dedicated to finding meaningful treatments for people living with this aggressive disease and will continue to study Tecentriq in mTNBC.”

Tecentriq was granted accelerated approval by the FDA for the mTNBC indication in March 2019, making it the first immunotherapy agent to be approved in this setting. Approval was based on the progression-free survival (PFS) results of the Phase III IMpassion130 study for people with mTNBC whose tumors express PD-L1 (≥1%). Continued approval for this indication was contingent upon the results of IMpassion131, the postmarketing requirement (PMR). This study did not meet its primary endpoint of PFS for the initial (first-line) treatment of people with mTNBC in the PD-L1-positive population. The results of both studies were discussed at the FDA Oncology Drugs Advisory Committee (ODAC), which voted 7 to 2 on April 27, 2021, in favor of maintaining the accelerated approval of Tecentriq in combination with nab-paclitaxel for the treatment of people with PD-L1-positive mTNBC. Since then, Genentech has been working diligently with the FDA on a possible alternative PMR. However due to the recent changes in the treatment landscape, the FDA no longer considers it appropriate to maintain the accelerated approval. This led to the difficult decision to voluntarily withdraw the U.S. mTNBC indication.