Stivarga First Drug in a Decade Approved by the FDA for Liver Cancer

Web Exclusives - FDA Approvals

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

The new indication of regorafenib for liver cancer was based on the RESORCE clinical trial, an international, randomized, double-blind, placebo-­controlled study involving 573 adults with HCC that progressed after sorafenib therapy.

The major efficacy outcome measure was overall survival (OS); other outcome measures included progression-free survival (PFS), overall response rate (ORR), and duration of response.

The median OS was 10.6 months in the regorafenib group versus 7.8 months in the placebo group, a significant difference (P <.0001). The median PFS was 3.4 months in the regorafenib group compared with 1.5 months in the placebo group, also a significant difference (P <.0001). The ORR was 11% in the regorafenib group versus 4% in the placebo group.

The most common (≥20%) all-grade adverse reactions reported with regorafenib plus best supportive care in patients with liver cancer were pain, hand–foot skin reaction, asthenia or fatigue, diarrhea, decreased appetite or food intake, hypertension, infection, dysphonia, fever, mucositis, weight loss, and rash.

Regorafenib includes a box warning about the potential for severe and fatal hepatotoxicity.

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Last modified: August 10, 2017
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