FDA Gives Green Light to Stivarga HCC Indication

A total of 573 patients with HCC whose tumors progressed after receiving sorafenib took part in the Stivarga trial
A total of 573 patients with HCC whose tumors progressed after receiving sorafenib took part in the Stivarga trial

The Food and Drug Administrations (FDA) has expanded the approval of Stivarga (regorafenib; Bayer) to include the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib.

“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 FDAs Oncology Center of Excellence.

A randomized controlled trial involving 573 patients with HCC whose tumors progressed after receiving sorafenib demonstrated the safety and efficacy of Stivarga in this population. The results showed that the median overall survival was 10.6 months vs. 7.8 months for the Stivarga and placebo groups, respectively. Progression-free survival was also better for the Stivarga group; 3.1 months compared to 1.5 months for placebo. Overall response rate was 11% versus 4% for Stivarga vs. placebo, respectively.

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Stivarga, a kinase inhibitor that blocks several enzymes that promote cancer growth, is also approved to treat metastatic colorectal cancer in patients who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an antiVEGF therapy, and, if RAS wild-type, an anti-EGFR therapy. It is also indicated for locally advanced, unresectable or metastatic gastrointestinal stromal tumor (GIST) in patients who have been previously treated with imatinib mesylate and sunitinib malate.  

For more information visit FDA.gov.