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Exelixis Announces Partner Takeda Receives Approval in Japan for CABOMETYX® (cabozantinib) Tablets for the Treatment of Curatively Unresectable or Metastatic Renal Cell Carcinoma
ALAMEDA, Calif.--(BUSINESS WIRE)-- Exelixis, Inc. (NASDAQ: EXEL) today announced that Takeda Pharmaceutical Company Limited (Takeda), its partner responsible
About this update from Exelixis, Inc.
[{"type":"text","content":" ALAMEDA, Calif.--(BUSINESS WIRE)--\nExelixis, Inc. (NASDAQ: EXEL) today announced that Takeda Pharmaceutical Company Limited (Takeda), its partner responsible for the clinical development and commercialization of CABOMETYX® (cabozantinib) in Japan, received approval from the Japanese Ministry of Health, Labor and Welfare to manufacture and market CABOMETYX as a treatment for patients with curatively unresectable or metastatic renal cell carcinoma (RCC).\n\n\nThe approval is based on the results of three clinical trials: METEOR, the Exelixis-sponsored phase 3 pivotal trial of cabozantinib versus everolimus in patients with advanced RCC that experienced disease progression following treatment with at least one prior VEGF receptor tyrosine kinase inhibitor (VEGFR-TKI); CABOSUN, the Alliance for Clinical Trials in Oncology-sponsored phase 2 trial comparing cabozantinib with sunitinib in patients with previously untreated advanced RCC with intermediate- or poor-risk disease; and Cabozantinib-2001, a Takeda-sponsored phase 2 trial in 35 Japanese patients with advanced RCC who had progressed after prior VEGFR-TKI therapy.\n\n\n“Nearly 17,000 new cases of renal cell carcinoma are estimated to be diagnosed in Japan annually, and since many cases are diagnosed at an advanced stage, the prognosis remains poor for these patients,” said Michael M. Morrissey, Ph.D., President and Chief Executive Officer of Exelixis. “The approval of CABOMETYX is an important milestone for people with kidney cancer in Japan, and we are excited to continue our collaboration with Takeda as we work to bring more options to patients who need novel therapies.”\n\n\nPer the terms of Exelixis and Takeda’s collaboration and license agreement, Exelixis is eligible to receive a $31 million milestone payment from Takeda upon the first commercial sale of CABOMETYX for unresectable or metastatic RCC. In January 2020, Takeda applied for approval to manufacture and sell cabozantinib as a treatment for patients with unresectable hepatocellular carcinoma (HCC) that had progressed after prior systemic therapy in Japan, which triggered a $10 million milestone payment. Exelixis will also be eligible to receive further development, regulatory and first-sale milestone payments of up to $45 million from Takeda related both to previously treated and untreated RCC and previously trea...