Bristol-Myers Squibb’s shares opened the trading day with an impressive +2% as the US-based group announced that EMA had approved Opdivo (nivolumab) for the treatment of melanoma with involvement of lymph nodes or metastatic disease (Phases III and IV). Opdivo, therefore, is the only PD-1 immunotherapy to have been approved in Europe for as many as 8 indications for 6 solid tumor types. The approval reflects the positive results so far achieved in the Phase III CheckMate-238 clinical trial, designed to assess Opdivo 3 mg/kg vs Yervoy 10 mg/kg. The FDA had already approved the product for melanoma with involvement of lymph nodes last December.
BMS some days ago announced to the financial community that Opdivo delivered $1.627bn revenues in Q2 2018.