Stivarga gains FDA approval to treat liver cancer

Reuters

Reuters

Stivarga, a kinase inhibitor, operates by blocking a variety of enzymes that promote the growth of any cancerous cells.

This is the first FDA-approved treatment for a liver cancer in nearly 10 years.

"Limited treatment options are available for patients with liver cancer", Richard Pazdur, director of the FDA's Oncology Center of Excellence, said.

The phase 3 RESORCE study randomized 573 patients with HCC in a 2:1 ratio to receive best supportive care plus either Stivarga (n = 379) or placebo (n = 194).

Thursday, the FDA green-lighted Stivarga as a second-line treatment for patients with unresectable forms of the disease.

"We know that there are other drugs being studied in this area, but those would be one-off approvals-front line, second line-but not necessarily this continuum approach that we could actually offer physicians as they think about the totality of treatments for the patients", company oncology head Robert LaCaze told FiercePharma at October's European Society for Medical Oncology annual meeting. The overall response rate for patients taking Stivarga was 11 percent, compared to 4 percent of patients taking placebo. The trail measured the overall survival of patients after receiving treatment, the length of time tumors did not grow after treatment and the overall response rate of patients whose tumors shrank after treatment. The most common side effects included gastrointestinal and abdominal pain, skin reactions, fatigue, diarrhea, loss of appetite, high blood pressure and infection.

Treatment with regorafinib is associated with serious risks, including hepatotoxicity, infections, hemorrhage, gastrointestinal perforation or fistula, dermatological toxicity, hypertension, cardiac ischemia and infarction, reversible posterior leukoencephalopathy syndrome, 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. And both genders of child-bearing age who take the drug should use contraception, the agency added. The drug is separately undergoing regulatory review for the HCC indication in the EU, Japan and China. It also received Orphan Drug designation, which delivers motivations to help and inspire the progression of drugs to cute rare diseases.

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