Ipsen: EMA validates an application for cabometyx.
(CercleFinance.com) - Ipsen has announced that the European Medicines Agency (EMA) has validated the application for the addition of a new indication in the first-line treatment of advanced kidney carcinoma (aRCC) for Cabometyx (cabozantinib).
This application is based on the results of the CABOSUN Phase II trial demonstrating that Cabometyx prolongs progression-free survival compared with sunitinib for patients with a previously untreated intermediate or high risk aRCC.
If approved, Cabometyx will be the first and only monotherapy treatment to have proven clinical efficacy that is superior to that of the primary (sunitinib) and second-line (everolimus) reference treatments for advanced kidney carcinoma.
Copyright (c) 2017 CercleFinance.com. All rights reserved.
This application is based on the results of the CABOSUN Phase II trial demonstrating that Cabometyx prolongs progression-free survival compared with sunitinib for patients with a previously untreated intermediate or high risk aRCC.
If approved, Cabometyx will be the first and only monotherapy treatment to have proven clinical efficacy that is superior to that of the primary (sunitinib) and second-line (everolimus) reference treatments for advanced kidney carcinoma.
Copyright (c) 2017 CercleFinance.com. All rights reserved.