Posted by Michael Wonder on 01 Jul 2018
Bristol-Myers Squibb receives positive CHMP opinion recommending approval of Opdivo (nivolumab) for the adjuvant treatment of adult patients with melanoma
29 June 2018 - First and only PD-1 agent to receive positive CHMP opinion in the adjuvant setting.
Bristol-Myers Squibb Company today announced that the CHMP of the EMA has recommended expanded approval of the current indications for Opdivo (nivolumab) to include the adjuvant treatment of adult patients with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection. This is the first time the CHMP has recommended a PD-1 inhibitor as an adjuvant treatment for any type of cancer. The CHMP recommendation will now be reviewed by the European Commission, which has the authority to approve medicines for the European Union.
The CHMP recommendation is based on data from the phase 3 CheckMate-238 trial, an ongoing, randomized double-blind study of Opdivo 3 mg/kg versus Yervoy (ipilimumab) 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.
