In the U.S., the Food and Drug Administration (FDA) has accepted for priority review the Biologics License Application (BLA) for previously treated advanced melanoma and the Prescription Drug User Fee Act (PDUFA) goal date for a decision is March 30, 2015.
The FDA also granted Opdivo Breakthrough Therapy status for this indication. In the European Union, the European Medicines Agency (EMA) has validated for review the Marketing Authorization Application (MAA) for Opdivo in advanced melanoma. The application has also been granted accelerated assessment by the EMA’s Committee for Medicinal Products for Human Use (CHMP).
"The filing acceptance and validation of our Opdivo applications by the FDA and EMA represent significant steps forward in our commitment to delivering innovative immuno-oncology treatments to patients with cancer around the world," said Michael Giordano, MD, senior vice president, Head of Oncology Development, Bristol-Myers Squibb.
"Additionally, the Breakthrough Therapy Designation and the accelerated assessment for advanced melanoma underscore our focus on developing treatments for diseases in which a significant unmet medical need remains."
About the U.S. Biologics License Application
The U.S. BLA is based on data from CheckMate -037, a multinational, multicenter, randomized open-label Phase 3 trial evaluating Opdivo compared to the physician’s choice of either dacarbazine (DTIC) or carboplatin/paclitaxel in patients with unresectable or metastatic melanoma who have been previously treated with Yervoy and, if BRAF-mutation positive, a BRAF inhibitor. Interim data from CheckMate -037 will be highlighted at an ESMO 2014 Congress press briefing on September 29 in the morning and presented during the Presidential Symposium at 4 p.m. CEST (Abstract #LBA3_PR).
In the U.S., priority review status is granted for applications for drugs that treat a serious condition and, if approved, would be a significant improvement in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions when compared to standard applications. Breakthrough Therapy Designation, according to the FDA, is intended to expedite the development and review of drugs for serious or life-threatening conditions. The criteria for this designation require preliminary clinical evidence that demonstrates that the drug may have substantial improvement on at least one clinically significant endpoint over available therapy.
About the E.U. Marketing Authorization Applications
The MAA submitted to the EMA in advanced melanoma is also supported by data from CheckMate -037. Accelerated assessment procedure may be requested for medicinal products of major interest from the point of view of public health and, in particular, from the point of view of therapeutic innovation. The acceptance of accelerated assessment by the CHMP could shorten the review time of Opdivo in advanced melanoma by approximately two months.