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FDA OK for Stivarga ends decade-long drought in liver cancer

Bayer's medicine wins US approval to treat hepatocellular carcinoma

Bayer

Bayer has bagged FDA approval for Stivarga as a treatment for patients with a common form of liver cancer, becoming the first new drug for the disease in the US for almost 10 years.

Oral multikinase inhibitor Stivarga (regorafenib) has been cleared by the US regulator for patients with hepatocellular carcinoma (HCC) who have been previously treated with Bayer's older drug Nexavar (sorafenib).

"Limited treatment options are available for patients with liver cancer," said Richard Pazdur, acting director of the FDA's Office of Hematology and Oncology Products. "This is the first time patients with HCC have had an FDA-approved treatment that can be used if their cancer has stopped responding to initial treatment with sorafenib."

In a statement Bayer said Stivarga "is the first and only treatment to demonstrate significant improvement in overall survival in second-line HCC patients", extending overall survival (OS) by around three months in the RESORCE trial.

According to the National Cancer Institute (NCI), more than 40,000 people will be diagnosed with liver cancer in 2017 and approximately 29,000 will die as a result. HCC is the most common form of liver cancer.

This is the third indication for Stivarga, which was approved for third-line colorectal cancer treatment in 2012 and as a second-line therapy for gastrointestinal stromal tumours (GIST) a year later, and the new approval will be a big help towards Bayer's ambition to develop the drug into a €1bn-plus product.

Last year Stivarga brought in €275m - so it still has a long way to go - and grew 9% to contribute another €75m to the company's coffers according to Bayer's just-published first-quarter results which showed a 7% in pharma sales to €4.26bn. Nexavar slipped 3% to €213m in the first quarter.

Along with liver cancer Bayer is also carrying out studies aimed at moving Stivarga up the treatment pathway in colorectal cancer, with a trial (ARGO) due to report results in 2018 looking at the drug as an adjuvant to surgery.

Article by
Phil Taylor

28th April 2017

From: Regulatory

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