Bayer: FDA approves liver cancer drug Stivarga.
(CercleFinance.com) - Bayer said on Friday that the US Food and Drug Administration (FDA) has approved of Stivarga tablets for the second-line treatment of patients with hepatocellular carcinoma (HCC).
In clinical trials, Stivarga has been shown to provide a statistically significant and clinically meaningful improvement in overall survival versus placebo, the German firm said.
The median overall survival was 10.6 months versus 7.8 months, which translated into a 37% reduction in the risk of death.
The number of deaths in each arm included 233 of 379 (62%) with Stivarga and 140 of 194 (72%) with placebo.
The FDA's approval only relates to people who have been previously treated with Nexavar, another drug belonging to Bayer's portfolio.
Bayer shares are currently up 1.2% at 114 euros in Frankfurt.
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