This approval allows for the marketing of cabozantinib in this indication in all 28 member states of the European Union, Norway and Iceland.
US FDA approval for the same indication came in January.
Giuseppe Procopio, M.D., Head of the Genitourinary Unit at Fondazione Istituto Nazionale Tumori Milan, stated “The value of treatment with cabozantinib has been corroborated by the data generated in clinical trials, and since 2016 physicians have also witnessed the potential of it when treating patients following VEGF-targeted therapy. For both of these reasons, physicians will be pleased to soon have access to this new first-line treatment option for intermediate- or poor-risk advanced RCC patients.”
The decision is based on the CABOSUN trial, which demonstrated that cabozantinib significantly prolongs progression-free survival (PFS) compared to sunitinib in treatment-naive aRCC patients with intermediate- or poor-risk.
Cabozantinib is the first and only monotherapy to demonstrate superior clinical efficacy over sunitinib in treatment-naïve aRCC patients with intermediate- or poor-risk.
The American Cancer Society’s 2017 statistics cite kidney cancer as one of the top ten most commonly diagnosed forms of cancer among both men and women in the U.S.
Clear cell RCC is the most common type of kidney cancer in adults.
If detected in its early stages, the five-year survival rate for RCC is high.
For patients with advanced- or late-stage metastatic RCC, however, the five-year survival rate is only 12% with no identified cure for the disease.
Approximately 30,000 patients in the U.S. and 68,000 globally require treatment.
“Today’s EC approval is a step forward for advanced kidney cancer patients in Europe who will be able to access a new oral first-line treatment option that offers significant improvement over the standard of care,” said Harout Semerjian, Executive Vice President, Chief Commercial Officer, Ipsen. “Ipsen remains committed to improving patients’ lives by continuing to develop new therapies and expanding the potential of cabozantinib across different indications.”