Bristol-Myer Squibb’s Opdivo could outshine Merck’s recently approved Keytruda for the treatment of advanced melanoma.
By Aine Slowey, Lead Analyst
3 October 2014
I am the Lead Analyst for cardiovascular and metabolic diseases at Datamonitor Healthcare. I have a DPhil in Organic Che...
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On 4 September 2014, Merck & Co announced the earlier-than-expected approval of Keytruda (pembrolizumab) for the treatment of metastatic or BRAF V600 mutation-positive melanoma that no longer responds to Yervoy (ipilimumab; Bristol-Myers Squibb) or BRAF inhibitors.
Keytruda has already demonstrated its efficacy in previously untreated patients, and extensive off-label use of Keytruda is anticipated for melanoma patients. Merck has gained a significant advantage by reaching the US market ahead of its rivals and rapid uptake of Keytruda is anticipated after launch.
However, Bristol-Myers Squibb revealed Phase III results in melanoma for the programmed cell death-1 (PD-1) inhibitor Opdivo (nivolumab) at the European Society for Medical Oncology (ESMO) meeting on 29 September that support the biologic license application (BLA) for which the US FDA recently granted priority review – data that may outshine Merck & Co’s competing drug.
Merck beat Bristol-Myers in the race to bring the first PD-1 immune checkpoint inhibitor to the US market when the FDA approved Keytruda (pembrolizumab) for previously treated unresectable or metastatic melanoma. But with the Phase III Opdivo results that were presented at ESMO, the BMS immunotherapy could win approval in the US based on a higher response rate in a similar patient population.
Posted in Oncology.