Application for Darzalex + Velcade + dexamethasone in multiple myeloma granted priority review by FDA.

The FDA has granted a Priority Review for the supplemental Biologics License Application (sBLA) for the use of Darzalex (daratumumab) in combination with bortezomib, thalidomide and dexamethasone (VTd), from Janssen Biotech, as treatment for patients newly diagnosed with multiple myeloma who are candidates for autologous stem cell transplant (ASCT). Priority Review is an FDA designation for drugs that treat a serious condition and may provide a significant improvement in safety or efficacy. The FDA assigned a Prescription Drug User Fee Act (PDUFA) target date of September 26, 2019 to take a decision on daratumumab in this indication.

The sBLA submission is based on data from the Phase III CASSIOPEIA study of daratumumab in combination with VTd as treatment for patients newly diagnosed with multiple myeloma who are candidates for ASCT. The study is sponsored by the French Intergroupe Francophone du Myelome (IFM) in collaboration with the Dutch-Belgian Cooperative Trial Group for Hematology Oncology (HOVON) and Janssen. Genmab announced topline results from the trial in October 2018 and the American Society of Clinical Oncology (ASCO) accepted an abstract containing more complete data, submitted by Janssen, for oral presentation at the 2019 ASCO Annual meeting in June 2019.