Posted by Michael Wonder on 31 Jul 2018
European Commission approves Bristol-Myers Squibb’s Opdivo (nivolumab) for the adjuvant treatment of adult patients with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection
31 July 2018 - Opdivo is the first and only PD-1 agent with an approved adjuvant therapy indication in the European Union.
Bristol-Myers Squibb Company today announced that the European Commission has approved Opdivo (nivolumab) for the adjuvant treatment of adult patients with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection. This indication is for both BRAF mutant and wild-type melanoma patients. With this decision, Opdivo becomes the first and only PD-1 therapy to receive an EC approval in the adjuvant setting and has gained its eighth indication across six distinct tumour types in the European Union.
The EU approval is based on results from the ongoing Phase 3 randomised double-blind CheckMate-238 trial, which studied Opdivo 3 mg/kg versus Yervoy 10 mg/kg in patients who have undergone complete resection of stage IIIB/C or stage IV melanoma according to the AJCC Cancer Staging Manual 7th edition.
