Posted by Michael Wonder on 11 Sep 2017
Ipsen receives validation from European Medicines Agency for the application of a new indication for Cabometyx (cabozantinib) for first-line treatment of advanced renal cell carcinoma in adults
8 September 2017 - The filing in first line advanced renal cell carcinoma is based on the CABOSUN results, a phase II trial demonstrating that Cabometyx prolongs progression-free survival in treatment-naive patients with intermediate- or poor-risk advanced RCC compared to sunitinib.
Ipsen today announced that the EMA has validated the application for variation to the Cabometyx (cabozantinib) marketing authorisation for the addition of a new indication in first-line treatment of advanced renal cell carcinoma.
If approved, Cabometyx would be the first and only single-agent treatment to demonstrate superior clinical efficacy over the standard of care in both first line (vs. sunitinib) and second line (vs. everolimus) aRCC.
