EXEL - Exelixis opts not to seek label expansion for Cabometyx

Exelixis (NASDAQ:EXEL) announced on Monday that the company would no longer pursue its planned submission of the supplemental New Drug Application for its cancer therapy, Cabometyx, to the U.S. Food and Drug Administration (FDA). The decision followed an analysis from the phase 3 COSMIC-312 trial, which was designed to evaluate Cabometyx (cabozantinib) with Roche's (OTCQX:RHHBY) atezolizumab (tecentriq) against kinase inhibitor, Sorafenib as a first-line option in advanced hepatocellular carcinoma. The analysis, which tested the second primary endpoint of overall survival (OS), indicated "neither improvement nor detriment in OS" for the experimental combo compared to Sorafenib, Exelixis (EXEL) said, adding that the full results would be presented at a future medical meeting. The company shares are trading ~3% lower in the pre-market currently.

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Exelixis opts not to seek label expansion for Cabometyx