Bristol-Myers Squibb has received a positive Committee for Medicinal Products for Human Use (CHMP) opinion recommending approval of its Opdivo (nivolumab) four-week dosing schedule for the adjuvant treatment of adult patients with melanoma.
The CHMP of the European Medicines Agency (EMA) has recommended approval of Opdivo flat dosing schedule of 240 mg infused over 30 minutes every two weeks (Q2W) or 480 mg infused over 60 minutes every four weeks (Q4W) for the adjuvant treatment of adult patients with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection.
The CHMP recommendation will now be reviewed by the European Commission, which has the authority to approve medicines for the European Union.
Ralu Vlad, Pharm.D, development team lead, product design and delivery, Bristol-Myers Squibb, said: “This positive CHMP opinion for Opdivo two and four-week dosing reinforces our commitment to offering flexible dosing options for patients, caregivers and healthcare providers.
“We look forward to the European Commission’s decision and potentially bringing this new Opdivo dosing regimen to patients as quickly as possible.”