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J&J-Genmab's Darzalex gets US FDA approval for another blood cancer indication

Genmab A/S said the U.S. Food and Drug Administration has approved the expanded use of Darzalex in combination with dexamethasone, thalidomide and chemotherapy drug bortezomib to treat certain blood cancer patients.

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The U.S. regulator approved the combination for the treatment of newly diagnosed patients with multiple myeloma who are candidates for autologous stem cell transplant. The approval is based on results from a phase 3 trial called Cassiopeia.

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, in which a patient's own stem cells are taken from the bone marrow and transplanted back at a later time.

Johnson & Johnson's Janssen Biotech Inc. submitted the supplemental drug application with the FDA in March. Janssen is developing Darzalex, or daratumumab, as part of an August 2012 exclusive worldwide license agreement with Copenhagen-based Genmab.

The FDA granted a priority review to the application, which is granted to drugs that can treat serious conditions and may provide a significant improvement in safety or efficacy.

Japan's Ministry of Health, Labour and Welfare approved Darzalex, in combination with bortezomib, melphalan and prednisone, in August for treating patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant.

Darzalex is approved in the U.S. and EU for a number of multiple myeloma indications.