FDA Approves Regorafenib for Second-line in Hepatocellular Carcinoma

FDA expands approval of Stivarga to include liver cancer

Apart from these, Stivarga will also block enzymes present in the "vascular endothelial growth factor pathway".

Earlier today, the approved usage of Stivarga (regorafenib) was expanded by the FDA.

Regorafenib increased median overall survival to 10.6 months from 7.8 months with placebo. HCC originates in the liver and was the most common form of liver cancer.

The safety and efficacy of Stivarga for treatment of HCC were studied in a randomized trial of 573 patients with HCC whose tumors had progressed after receiving sorafenib.

The approval marked the first FDA-approved treatment for liver cancer in nearly a decade.

About 40,710 people will be diagnosed with liver cancers in 2017 and about 28,920 will die of the diseases, according to the National Cancer Institute. The trial measured overall survival, progression-free survival (PFS), and the overall response rate (ORR).

The FDA's approval is based on data from the global, multicenter, placebo-controlled Phase III RESORCE [REgorafenib after SORafenib in patients with hepatoCEllular carcinoma; NCT 01774344] trial, which investigated patients with HCC whose disease had progressed during treatment with Nexavar.

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.

The known common side effects of Stivarga include diarrhea, abdominal and gastrointestinal pain, fatigue, hand-foot skin reaction, dysphonia, reduced appetite, hypertension, inflammation of the mucous membranes, fever, weight loss, nausea, infection, and rash.

The FDA warned regorafenib is associated with serious risks, including liver damage, infections, heavy bleeding, holes in the stomach or intestines, skin damage, hypertension, problems with blood flow to the heart, temporary brain swelling and wound healing complications.

Women who are pregnant or breastfeeding should not take Stivarga because it may cause harm to a developing fetus or a newborn baby. The approval follows results that showed Stivarga was the first drug to post an overall survival advantage in the population, earning the med the agency's priority tag.

3 Ryerson, A. B., et al (2016), Annual Report to the Nation on the Status of Cancer, 1975-2012, featuring the increasing incidence of liver cancer.



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