Business
Exelixis Announces Takeda and Ono Submit Supplemental Application for CABOMETYX® (cabozantinib) in Combination with OPDIVO® (nivolumab) for the Treatment of Unresectable, Advanced or Metastatic Renal Cell Carcinoma in Japan
– Submission based on the CheckMate -9ER phase 3 pivotal trial, which showed CABOMETYX in combination with OPDIVO improved overall survival and doubled
About this update from Exelixis, Inc.
[{"type":"text","content":"\n– Submission based on the CheckMate -9ER phase 3 pivotal trial, which showed CABOMETYX in combination with OPDIVO improved overall survival and doubled median progression-free survival and objective response rate versus sunitinib –\n\n 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, and Ono Pharmaceutical Co., Ltd. (Ono), have submitted a supplemental application to the Japanese Ministry of Health, Labour and Welfare (MHLW) for Manufacturing and Marketing approval of CABOMETYX in combination with OPDIVO® (nivolumab) for the treatment of patients with unresectable, advanced or metastatic renal cell carcinoma (RCC).\n\nTakeda and Ono’s application is based on the results of CheckMate -9ER, a phase 3 pivotal trial evaluating CABOMETYX in combination with OPDIVO in previously untreated patients with advanced or metastatic RCC compared with sunitinib. In CheckMate -9ER, CABOMETYX in combination with OPDIVO demonstrated superior overall survival, doubled median progression-free survival and objective response rate, and demonstrated a favorable safety profile versus sunitinib. These results were presented as a Proffered Paper during a Presidential Symposium at the European Society for Medical Oncology Virtual Congress 2020.\n\n“Following our recent announcement that the U.S. FDA accepted and granted Priority Review to our supplemental new drug application for CABOMETYX in combination with OPDIVO for the treatment of advanced renal cell carcinoma, we’re excited that our partner Takeda along with Ono have also advanced this combination regimen toward potential regulatory approval in Japan,” said Gisela Schwab, M.D., President, Product Development and Medical Affairs and Chief Medical Officer, Exelixis. “The results of the CheckMate -9ER trial suggest CABOMETYX in combination with OPDIVO may become an important new treatment option for patients with advanced kidney cancer in need of new therapies.”\n\nPer the terms of Exelixis and Takeda’s collaboration and license agreement, Exelixis is eligible to receive a $10 million milestone payment from Takeda as a result of this latest submission for RCC. Following the milestone associated with thi...