CHMP recommends expanded approval of Opdivo to include adjuvant treatment of adults with melanoma in lymph nodes or metastases who have undergone complete resection.- BMS.
Bristol-Myers Squibb announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency 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 (EC), which has the authority to approve medicines for the European Union (EU).
The CHMP recommendation is based on data from the phase III 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. The FDA expanded the approval of Opdivo to include the adjuvant treatment of patients with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection in December 2017.
Learning Zones
The Learning Zones are an educational resource for healthcare professionals that provide medical information on the epidemiology, pathophysiology and burden of disease, as well as diagnostic techniques and treatment regimens.
3 mins