FDA approves cabozantinib for treatment-experienced patients with aggressive liver cancer


FDA approves cabozantinib to treat patients with hepatocellular carcinoma, a community in need of new therapeutic options.

headshot of Gisela Schwab(unkonwn.jpeg)


A treatment recently approved by FDA to treat liver cancer is already available on the market.

Cabozantinib (Cabometyx, Exelixis) tablets treat patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib (Nexavar, Bayer). HCC is the most common form of liver cancer and the fastest-rising cause of cancer-related death in the United States, according to Exelixis.

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Because Cabometyx is already approved to treat renal cell carcinoma (RCC), it is already in the distribution chain, Gisela M. Schwab, MD, president of product development and medical affairs and chief medical officer at Exelixis, told FormularyWatch.

Cabometyx’s wholesale acquisition cost is $18,365.41, Schwab added.

“This new indication for Cabometyx is an important treatment advance for patients with this aggressive form of liver cancer, a community in need of new therapeutic options,” said Michael M. Morrissey, PhD, president and CEO of Exelixis, in a statement from the company.

Cabometyx is distinct from other approved treatment options in that it targets multiple pathways involved in HCC, and “has now demonstrated its ability to meaningfully extend overall survival in 2 large, randomized global pivotal trials in advanced renal cell carcinoma and HCC,” Schwab said.

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In a clinical trial, the media overall survival (OS) was 10.2 months with Cabometyx versus 8.0 months with placebo. Median progression-free survival (PFS) was more than doubled at 5.2 months with Cabometyx and 1.9 months with placebo, Schwab said. Notably, disease control (partial response or stable disease) was achieved by 64% of the Cabometyx group compared with 33% of the placebo group.

The recommended cabozantinib dose is 60 mg orally, once daily at least 1 hour before or 2 hours after eating.

Exelixis is committed to making sure that every patient who is prescribed Cabometyx is able to receive it, regardless of their personal financial limitations, Schwab said. “Exelixis continues to provide assistance for all eligible patients prescribed Cabometyx through our Exelixis Access Services (EASE) program,” she said.

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