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Tecentriq did not meet the primary end point in a postmarketing study as a first-line treatment.
Genentech has withdrawn the U.S. accelerated approval for Tecentriq (atezolizumab) in combination with chemotherapy (Celgene’s Abraxane, albumin-bound paclitaxel) for the treatment of adults with unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) whose tumors express PD-L1.
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 results of the phase 3 IMpassion130 study.
Continued approval was contingent upon the results of IMpassion131, which was a postmarketing commitment required by the FDA. This study did not meet its primary end point of progression-free survival for first-line treatment of people with mTNBC.
Although the FDA Oncology Drugs Advisory Committee voted 7 to 2 on April 27, 2021, in favor of maintaining the accelerated approval of Tecentriq, Genentech officials made the decision to withdraw the indication because of changes in the treatment landscape, they said in a statement.
One of those changes was the accelerated approval of Merck’s Keytruda (pembrolizumab) in November 2020 for the same indication.
“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,” Levi Garraway, M.D., Ph.D., chief medical officer and head of global product development at Genentech, said in a statement. “We remain dedicated to finding meaningful treatments for people living with this aggressive disease and will continue to study Tecentriq in mTNBC.”
This decision only impacts the mTNBC indication of Tecentriq in the United States. Tecentriq is also approved in the United States to treat urothelial carcinoma, both small cell and nonsmall cell lung cancer, hepatocellular carcinoma, and melanoma.
Genentech is a member of the Roche Group.