Posted by Michael Wonder on 24 Mar 2017
Bristol-Myers Squibb receives positive CHMP opinion recommending Opdivo (nivolumab) for the treatment of squamous cell cancer of the head and neck in adults progressing on or after platinum-based therapy
24 March 2017 - Positive opinion based on overall survival benefit demonstrated in the Phase 3 CheckMate -141 trial.
Bristol-Myers Squibb today announced that the CHMP has recommended the approval of Opdivo as monotherapy for the treatment of squamous cell cancer of the head and neck (SCCHN) in adults progressing on or after platinum-based therapy.
This CHMP recommendation will now be reviewed by the European Commission, which has the authority to approve medicines for the European Union. This is the first CHMP positive opinion to recommend a PD-1 inhibitor for this type of treatment for SCCHN.
Opdivo is already approved by the European Commission for six indications in four distinct tumour types.
