Johnson & Johnson has submitted an application with the U.S. Food and Drug Administration seeking approval for Darzalex in an additional blood cancer indication.
The New Brunswick, N.J.-based healthcare giant is seeking approval for Darzalex in combination with chemotherapy bortezomib, thalidomide and dexamethasone, to treat newly diagnosed multiple myeloma patients who are candidates for autologous stem cell transplant.
Multiple myeloma is an incurable blood cancer that forms in plasma cells, which are responsible for producing antibodies. Autologous stem cell transplant is a standard treatment for this type of cancer. A patient's own stem cells are taken from the bone marrow and transplanted back at a later time.
The application is based on a phase 3 study called Cassiopeia, which showed that more patients in the Darzalex combination arm responded to the treatment compared to those receiving only chemotherapy.
Johnson & Johnson unit Janssen Biotech Inc. licensed Darzalex, or daratumumab, from Copenhagen-based drugmaker Genmab A/S in 2012.
The FDA has already approved Darzalex to treat newly diagnosed multiple myeloma patients who are ineligible for stem cell transplant.
Johnson & Johnson recently submitted an application with the European Medicines Agency seeking approval to expand the use of Darzalex for patients who are not candidates for stem cell transplant. The therapy is already approved in the EU in combination with either Celgene Corp.'s Revlimid or Takeda Pharmaceutical Co. Ltd.'s Velcade and dexamethasone for treating adults with multiple myeloma who have received at least one prior therapy.