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FDA NewsNewsworthy

Stivarga First Drug in a Decade to Receive FDA Approval for Liver Cancer

June 2017 Vol 3 No 3

On April 27, 2017, the FDA approved Stivarga (regorafenib; from Bayer HealthCare) for the treatment of patients with liver cancer, or hepatocellular carcinoma (HCC), who had previously received Nexavar (sorafenib). This approval represents an important milestone for patients with liver cancer: it has been nearly 10 years since a new drug was approved by the FDA for liver cancer. Stivarga is an oral drug taken once daily.

“Limited treatment options are available for patients with liver cancer. 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,” said Richard Pazdur, MD, Director of the FDA’s Oncology Center of Excellence.

In the clinical trial that led to this approval for liver cancer, patients who received Stivarga once daily had longer overall survival than those who received a placebo.

The most common side effects reported with Stivarga in patients with liver cancer were pain, skin reaction, fatigue, diarrhea, decreased appetite, hypertension, infection, fever, mucositis, weight loss, and rash. Stivarga can lead to serious and potentially fatal liver toxicity. Liver function should be monitored before and during treatment.

Stivarga was previously approved for the treatment of colorectal cancer.

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Last modified: October 5, 2017