Bristol-Myers Squibb has received confirmation that the US Food and Drug Administration (FDA) has accepted its biologics licence application for ipilimumab for filing and review.
The company also announced that the application has received a priority review designation, which is granted to rugs that show major advances in treatment or provide therapy for an unmet clinical need.
Ipilimumab is intended for adults with advanced melanoma who have previously been treated.
The filing is based on a trial of the drug that compared overall survival of patients who received ipilimumab plus gp100 vaccine, only ipilimumab, and the control therapy of gp100 alone.
Ipilimumab is also being reviewed by the European Medicines Agency.
Source pharmaceutical-technology
