Takeda Submits New Drug Application in Japan for CABOMETYX® (cabozantinib) to Treat Advanced Hepatocellular Carcinoma

Exelixis Announces That Its Partner Takeda Has Submitted a Marketing Application in Japan for Cabometyx (cabozantinib) for the Treatment of Unresectable Hepatocellular Carcinoma That Has Progressed Following Prior Therapy

Liver cancer is the second leading cause of cancer-related deaths worldwide, with 800,000 new cases diagnosed annually and over 700,000 deaths attributed to the disease each year. China is also one of the countries with a high burden of liver cancer. Hepatocellular carcinoma (HCC) is the most common type of liver cancer; without treatment, the survival period for patients with advanced-stage HCC does not exceed six months.

Cabometyx is an oral small-molecule tyrosine kinase inhibitor developed by Exelixis, Inc. It inhibits the activity of c-Met, VEGFR2, as well as AXL and RET kinases. It has been approved in the United States for the treatment of advanced renal cell carcinoma (RCC). In January last year, the U.S. FDA expanded its indications to include the treatment of hepatocellular carcinoma.

▲Molecular structure of cabozantinib (Image source: Ed (Edgar181) [Public domain])

As a partner of Exelixis, Takeda is responsible for the clinical development and promotion of the drug in Japan. Data from two clinical trials indicated that patients treated with Cabometyx had significantly prolonged overall survival (OS) and progression-free survival (PFS) compared to the control group. Based on these data, Takeda has also submitted a marketing application in Japan.

Currently, cabozantinib has not yet been approved for marketing in China; however, Exelixis, Inc. submitted two import applications for cabozantinib to the Chinese NMPA last April.

We look forward to this innovative therapy benefiting more patients worldwide and extending their lives at an early date!

References:

[1] Exelixis Announces Partner Takeda Files New Drug Application in Japan for CABOMETYX® (cabozantinib) for Advanced Hepatocellular Carcinoma, Retrieved January 29, 2020, from https://www.businesswire.com/news/home/20200128005841/en

Original Title | New Drug for Liver Cancer Treatment Submits Marketing Application in Japan

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