EMA validates application from BMS for combination Opdivo (nivolumab) + Yervoy (ipilimumab) to treat advanced (unresectable or metastatic) melanoma .
The EMA has validated the application from BMS for Opdivo (nivolumab) + Yervoy (ipilimumab) to treat melanoma, the proposed new indication aims to extend the use of Opdivo monotherapy to its use in combination -- Opdivo in combination with Yervoy for the treatment of advanced (unresectable or metastatic) melanoma in adults.
The type II variation application in advanced melanoma is based on data from two studies: CheckMate -067, a pivotal Phase III study that evaluated the Opdivo+Yervoy regimen or Opdivo monotherapy vs. Yervoy monotherapy in adults with previously-untreated advanced melanoma, and the Phase II CheckMate -069, the first randomized trial evaluating the Opdivo+Yervoy regimen in patients with previously-untreated advanced melanoma, as well as supportive data from the Phase 1b CA209004 study in advanced melanoma.
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