Posted by Michael Wonder on 26 Mar 2018
Bristol-Myers Squibb receives positive CHMP opinion recommending approval of Opdivo four-week dosing schedule for advanced melanoma and previously treated renal cell carcinoma
26 March 2018 - Bristol-Myers Squibb Company today announced that the CHMP of the EMA has recommended approval of an every four-week (Q4W) Opdivo (nivolumab) dosing schedule of 480 mg infused over 60 minutes as an option for patients with advanced melanoma and previously treated renal cell carcinoma.
The CHMP also recommended approval of a two-week (Q2W) Opdivo dosing option of 240 mg infused over 30 minutes to replace weight-based dosing for all six approved monotherapy indications in the European Union.
The CHMP recommendation will now be reviewed by the European Commission, which has the authority to approve medicines for the European Union.
