The FDA has extended the review date for the supplemental BLA for Opdivo(nivolumab) to treat previously untreated advanced melanoma to 27 November 2015.

BMS announced that the FDA has extended the action date for the supplemental Biologics License Application (sBLA) for Opdivo (nivolumab) for the treatment of patients with previously untreated advanced melanoma. The company has taken the opportunity to submit additional data from the Opdivo clinical trial program to ensure the broadest data set, irrespective of BRAF status, was available for review. This submission constitutes a major amendment that will require additional time for review and the new FDA action date is November 27, 2015.

Comment: Opdivo was first approved in the US in December 2014 and in June 2015 for the EU, for previously treated patients with advanced melanoma and followed by a US approval in March 2015 for advanced lung cancer and for this indication, in the EU in July 2015.