BMS to file Opdivo at FDA in Q3 2014 for Advanced/Metastatic Melanoma..
Bristol-Myers Squibb Company announced that, following discussions with the FDA, the company is planning a third quarter submission of a Biologics Licensing Application (BLA) for Opdivo (nivolumab) for previously treated Advanced Melanoma. The advanced melanoma BLA is based on data from CHECKMARE-037, a multinational, multicenter, randomized open-label Phase III trial evaluating Opdivo compared to dacarbazine (DTIC) or carboplatin/paclitaxel in patients with unresectable or Metastatic Melanoma who have been previously treated with Yervoy (ipilimumab) and, if BRAF-mutation positive, a BRAF inhibitor regimen.
Learning Zones
The Learning Zones are an educational resource for healthcare professionals that provide medical information on the epidemiology, pathophysiology and burden of disease, as well as diagnostic techniques and treatment regimens.