Bayer seeks US, EU, Japan approval of Stivarga for second-line treatment of liver cancer

Bayer announced Monday the submission of marketing applications in the US, Europe and Japan seeking to expand approval of Stivarga (regorafenib) to include the second-line treatment of patients with unresectable hepatocellular carcinoma (HCC). The oral multi-kinase inhibitor is already authorised in a number of countries to treat metastatic colorectal cancer and metastatic gastrointestinal stromal tumours.

According to Bayer, the filings are based on data from the Phase III RESORCE trial, which investigated Stivarga in patients with unresectable HCC whose disease had progressed during treatment with the company's Nexavar (sorafenib). Results showed that Stivarga significantly improved overall survival (OS) compared to placebo, with the drug leading to a 37 percent reduction in the risk of death. Data indicated that the median OS was 10.6 months for Stivarga, versus 7.8 months in patients who received placebo.

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Principal study investigator Jordi Bruix remarked that Stivarga "is the first treatment to successfully deliver an overall survival benefit in the second-line setting for HCC and has the potential to change the treatment paradigm by becoming the new standard of care for patients who progress on [Nexavar]." Bayer added that in the US, Stivara has received fast track designation.

In 2011, Bayer entered into an agreement with Amgen's Onyx unit under which the latter receives a royalty on all global net sales of Stivarga in oncology. In September, Bayer said that it is targeting combined peak annual sales from five recently launched drugs, including Stivarga, of more than 10 billion euros ($11.1 billion), up from a prior estimate of at least 7.5 billion euros ($8.3 billion). The company predicts that Stivarga will generate peak sales of at least 1 billion euros ($1.1 billion).

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