Medarex, BMS delay ipilimumab following FDA meeting

PRINCETON, N.J. Medarex and Bristol-Myers Squibb have announced that after meeting with the Food and Drug Administration, that they will delay the Biologics License Application submission for ipilimumab, a drug for skin cancer.

The drug failed to meet an FDA requirement that at least 10 percent of patients respond to treatment, the companies said Dec. 10. The medicine is designed to combat skin cancers called melanomas that spread to other organs. The company was seeking approval of the drug for patients not helped by other treatments.

The companies don’t expect to submit an application for marketing approval to the FDA this year, Medarex and Bristol-Myers said April 25 in a statement.