Atezolizumab At Last: Roche Makes Its Immuno-Oncology Debut
This article was originally published in The Pink Sheet Daily
FDA's accelerated approval of Tecentriq, the first PD-L1 inhibitor, in bladder cancer is a major milestone for checkpoint inhibitors and for a disease with high unmet need; lung filing still under review.
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Roche's checkpoint inhibitor Tecentriq clears the EU approval hurdle in locally advanced or metastatic urothelial carcinoma and locally advanced or metastatic non-small cell lung cancer.
Confirmatory trial misses overall survival primary endpoint, raising question of whether US FDA will seek to revoke accelerated approval of PD-L1 inhibitor’s second-line bladder cancer indication, as it did with Avastin’s breast cancer claim.
Keeping Track: US FDA Expands Indications For Roche Tecentriq, Lucentis, Approves Second Infliximab Biosimilar
The latest drug development news and highlights from our FDA Performance Tracker.