Johnson & Johnson submitted a supplemental new drug application in Japan for Darzalex in front-line multiple myeloma.
Multiple myeloma is an incurable blood cancer that forms in plasma cells which are responsible for producing antibodies.
J&J unit Janssen Pharmaceutical KK submitted an application to Japan's Ministry of Health, Labor and Welfare seeking approval for Darzalex, combined with Takeda Pharmaceutical Co. Ltd.'s Velcade, Aspen Pharmacare Holdings Ltd.'s Alkeran and prednisone, for treating newly diagnosed multiple myeloma patients who are not eligible for autologous stem cell transplant. The application will be placed on priority review by the regulator.
The application is based on data from a 706-patient phase 3 trial, called Alcyone, which showed the Darzalex regimen reduced the risk of the disease getting worse or death by 50% in certain multiple myeloma patients. The Japanese regulator also gave Darzalex its orphan drug designation as a therapy for newly diagnosed multiple myeloma.
Darzalex was licensed by New Brunswick, N.J.-based Johnson & Johnson from Copenhagen-based Genmab A/S in 2012, and is approved in the U.S. and EU as a therapy for multiple myeloma.
Darzalex is already approved in Japan, for use in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, to treat adults with multiple myeloma that has recurred or has not responded to treatment.