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J&J's application for expanded use of Darzalex gets US FDA priority review


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J&J's application for expanded use of Darzalex gets US FDA priority review

The U.S. Food and Drug Administration granted a priority review status to Johnson & Johnson's application for the use of a Darzalex combination to treat a certain type of blood cancer.

The priority review is granted for drugs that can treat serious conditions and may provide a significant improvement in safety or efficacy.

The company is seeking approval for Darzalex, or daratumumab, in combination with chemotherapy bortezomib, thalidomide and dexamethasone to treat newly diagnosed patients with multiple myeloma 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, in which a patient's own stem cells are taken from the bone marrow and transplanted back at a later time.

Johnson & Johnson unit Janssen Biotech Inc., which licensed Darzalex from Copenhagen-based Genmab A/S in 2012, submitted the application in March. The application was based on a phase 3 study named Cassiopeia, which showed that more patients in the Darzalex combination arm responded to the treatment compared to those receiving only chemotherapy.

The FDA is expected to reach a decision by Sept. 26 on the Darzalex combination to treat multiple myeloma.

The regulator has already approved Darzalex to treat multiple myeloma patients who are ineligible for stem cell transplant.