Exelixis and Ipsen Announce European Approval of Cabometyx for Previously Untreated Intermediate- or Poor-Risk Advanced Renal Cell Carcinoma

  • Exelixis will receive a milestone payment of $50 million
  • Approval based on Cabometyx vs versus sunitinib in CABOSUN trial
  • Cabometyx was approved for reimbursement in most European countries by May of 2018

Exelixis (Nasdaq:EXEL) announced on 5/17/18 that its partner Ipsen received approval from the European Commission (EC) for Cabometyx (cabozantinib) 20 mg, 40 mg and 60 mg for the first-line treatment of adults with intermediate- or poor-risk advanced renal cell carcinoma (RCC) in the European Union.
“The expanded marketing authorization of Cabometyx to include previously untreated patients in Europe with intermediate- or poor-risk advanced kidney cancer is an exciting milestone for a patient population in need of more treatment options,” said Michael M. Morrissey, Ph.D., President and Chief Executive Officer of Exelixis. “We look forward to our continued collaboration with our partners Ipsen and Takeda to bring new options to more patients with difficult-to-treat cancers in Europe and around the world.”

Under the terms of the Collaboration and License Agreement with Ipsen, Exelixis will receive a milestone payment of $50 million for the EC approval, of which approximately $46 million was recognized as collaboration revenue in the first quarter of 2018. The payment will be made by Ipsen within the next 70 days.

Cabometyx was approved in the European Union in September 2016 for the treatment of advanced RCC in adults following prior vascular endothelial growth factor (VEGF)-targeted therapy. The expanded EC approval to include first-line treatment is based on results of the CABOSUN trial, which met its primary endpoint of improved progression-free survival (PFS) compared with sunitinib in patients with previously untreated advanced RCC determined to be intermediate- or poor-risk by the International Metastatic RCC Database Consortium (IMDC) criteria. In December 2017, the U.S. Food and Drug Administration (FDA) approved Cabometyx for the expanded indication of patients with advanced RCC based on the results from the CABOSUN trial.