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FDA Accepts Cabozantinib Application for Advanced HCC

Silas Inman @silasinman
Published: Wednesday, May 30, 2018

Gisela Schwab, MD

Gisela Schwab, MD
The FDA has accepted a supplemental new drug application (sNDA) for cabozantinib (Cabometyx) as a treatment for patients with previously-treated advanced hepatocellular carcinoma (HCC), according to a statement from the company developing the therapy, Exelixis.

Cabozantinib was initially approved by the FDA as a treatment for patients with medullary thyroid cancer in 2012. In April 2016, the agent received a new indication as a treatment for patients with advanced renal cell carcinoma (RCC) following one prior anti-angiogenic therapy. This approval was further expanded in December 2017 to include the treatment of patients with advanced RCC in the first-line setting. Numerous other trials exploring the agent remain ongoing.
Abou-Alfa GK, Meyer T, Cheng A-L, et al. Cabozantinib (C) versus placebo (P) in patients (pts) with advanced hepatocellular carcinoma (HCC) who have received prior sorafenib: Results from the randomized phase III CELESTIAL trial. J Clin Oncol. 2018;36 (suppl 4S; abstr 208).

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