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August 30, 2021August 27, 2021 – Drug manufacturer Roche is withdrawing a Tecentriq® (atezolizumab) metastatic triple negative breast cancer (mTNBC) indication following consultation with the U.S. FDA.
- In March 2019, Tecentriq received accelerated FDA approval for use in combination with chemotherapy to treat unresectable locally advanced or mTNBC in adults whose tumors express PD-L1, as determined by an FDA-approved test.
- As a condition of the approval, Tecentriq was required to meet a primary endpoint of progression- free survival in initial treatment of mTNBC in a clinical study enrolling PD-L1-positive patients. This was not achieved in the IMpassion131 post-marketing study.
- Tecentriq can still be used for all other FDA-approved indications, which include the treatment of urothelial carcinoma, hepatocellular carcinoma, small-cell lung cancer, melanoma, and non-small cell lung cancer. It first received FDA approval in 2016.
- Roche is working to notify healthcare professionals of the withdrawal and recommends that patients currently receiving Tecentriq for PD-L1-positive mTNBC speak to their healthcare providers.