Roche's Tecentriq wins U.S. approval for aggressive breast cancer

FILE PHOTO: The logo of Swiss drugmaker Roche is seen at its headquarters in Basel, Switzerland February 1, 2018. REUTERS/Arnd Wiegmann

The U.S. Food and Drug Administration approved Tecentriq mixed with the chemotherapy Abraxane to treat inoperable, locally advanced or metastatic triple-negative breast cancer in people whose tumors express PD-L1, a protein that may help cancers avoid detection by the immune system.The FDA’s approval was based on the drug cocktail’s record in studies that showed it delayed the progression of the disease.

Yet just 3 months later, a huge splash of cold water with the release of new data at ASCO showing no statistically significant overall survival benefit. In March I explained US_FDA shouldn't use surrogate endpoints like PFS for approvals:

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