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Bayer secures US FDA approval for Stivarga (regorafenib) tablets for second-line treatment of hepatocellular carcinoma.

M2 EQUITYBITES-April 28, 2017-Bayer secures US FDA approval for Stivarga (regorafenib) tablets for second-line treatment of hepatocellular carcinoma


Health care company Bayer reported on Thursday the receipt of approval from the US Food and Drug Administration (FDA) for Stivarga (regorafenib) tablets for the second-line treatment of patients with hepatocellular carcinoma (HCC), the most common form of liver cancer.

The company said Stivarga is the first and only treatment to demonstrate significant improvement in overall survival in second-line HCC patients who have been previously treated with Nexavar (sorafenib). Stivarga is an oral inhibitor of multiple kinases involved in normal cellular functioning and in pathological processes, including oncogenesis, tumor angiogenesis, metastasis and tumor immunity.

This US FDA approval of Stivarga (regorafenib) tablets is based on data from the company's international, multicentre, placebo-controlled Phase III RESORCE [REgorafenib after SORafenib in patients with hepatoCEllular carcinoma.

Under the company's RESORCE trial, Stivarga was shown to provide a statistically significant and clinically meaningful improvement in overall survival (OS) versus placebo; There was 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.

In conjunction, this US FDA approval expands the company's leadership in liver cancer, with a treatment plan in HCC involving use of Stivarga directly after progression on Nexavar. Regorafenib is a compound developed by Bayer.

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Publication:M2 EquityBites (EQB)
Date:Apr 28, 2017
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