|Bristol-Myers' Melanoma Combo Opdivo/Yervoy Gets FDA Nod|
|By Zacks Equity Research|
|Friday, 02 October 2015 19:45|
Bristol-Myers Squibb Company BMY announced that the combination of two of its immuno-oncology drugs, Opdivo and Yervoy, has been cleared by the FDA for the treatment of patients with BRAF V600 wild-type unresectable or metastatic melanoma.
The approval makes the Opdivo and Yervoy combination the first regimen of two immuno-oncology drugs.
The FDA granted accelerated approval to the Opdivo and Yervoy combination based on encouraging results from a phase II study (CheckMate - 069). Results revealed that patients treated with the combination regimen showed a much higher objective response rate (ORR) of 60% as compared to 11% in those under Yervoy monotherapy. This was also the primary endpoint of the study. Complete responses were also statistically higher in patients under the combination regimen as compared to those under Yervoy monotherapy. Continued approval for the melanoma indication depends on data from the confirmatory studies.
However, uptake of the combination regimen remains to be seen considering the high price tag. Recently, the biotech sector has been in the limelight, drawing a lot of criticism for its high-priced drugs.