The Japanese regulatory approval of cabometyx is based on results from two clinical trials: Phase 3 CELESTIAL and Phase 2 Cabozantinib-2003
Takeda Pharmaceutical Company global headquarters in Tokyo, Japan. (Credit: 妖精書士/Wikipedia.)
Japanese pharmaceutical company Takeda has received Japan’s Ministry of Health, Labor and Welfare approval of the use of cabometyx (cabozantinib) in treating unresectable hepatocellular carcinoma (HCC) after prior systemic therapy.
Takeda has entered into collaboration and license agreement with Exelixis, a US-based genomics-based drug discovery company, for the clinical development and commercialization of cabometyx in Japan.
Under the terms of the agreement, Takeda is expected to pay $15m in milestone payments, subject to first commercial sale of cabometyx for unresectable HCC. First sales are expected in the fourth quarter of 2020.
Takeda is expected to completely fund the development activities and holds the option to share the costs related to global clinical trials of cabometyx.
CELESTIAL and Cabozantinib-2003 trials supported cabometyx approval in Japan
In January 2020, Takeda’s application for regulatory approval for unresectable HCC in Japan triggered a $10m milestone payment.
The regulatory application is based on results from two clinical trials including Phase 3 CELESTIAL and Phase 2 Cabozantinib-2003, in Japanese patients with advanced HCC who received prior systemic therapy.
The CELESTIAL study supported the regulatory approval of cabometyx in the US and the EU for the treatment of HCC patients previously treated with sorafenib.
HCC is the upcoming cause of cancer-related deaths in the US, and patients with advanced HCC are said to survive less than six months without treatment.
Exelixis is entitled to receive additional payments for development, regulatory and first-sale milestones for future cabozantinib indications along with revenue milestones and royalties on net sales in Japan.
Exelixis president and CEO Michael M Morrissey said: “Hepatocellular carcinoma causes approximately 30,000 deaths in Japan each year and is a leading cause of cancer-related deaths worldwide.
“The approval of CABOMETYX in Japan is an exciting next step toward bringing this treatment to liver cancer patients who otherwise have limited treatment options following prior systemic therapy. We’re proud to collaborate with Takeda as we work to bring this treatment to patients in Japan.”