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J&J-Genmab's blood cancer drug Darzalex gets expanded approval in Japan

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Johnson & Johnson and Genmab A/S's drug Darzalex was approved by Japan's Ministry of Health, Labour and Welfare for treating certain patients with a type of blood cancer.

The Japanese regulator gave the nod to Darzalex, in combination with bortezomib, melphalan and prednisone, for treating patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant.

An autologous transplant uses healthy cells from a patient's own body.

Multiple myeloma is an incurable blood cancer characterized by an excess proliferation of plasma cells. About 6,313 new patients were expected to be diagnosed with the disease in Japan in 2018, and about 4,338 people were expected to die from the disease during that year.

The approval is based on a late-stage study called Alcyone, which included 706 newly diagnosed patients with multiple myeloma who are not eligible for autologous stem cell transplant. The trial showed that patients given the Darzalex combination had a reduction of the risk of disease progression or death by 50%.

J&J's Janssen Biotech Inc. is developing Darzalex, or daratumumab, as part of an August 2012 exclusive worldwide license agreement with Genmab. The Copenhagen-based biotechnology company is slated to receive a $7 million milestone payment from Janssen in connection with the approval and first commercial sale of Darzalex under the new label.

In 2017, Darzalex, combined with lenalidomide and dexamethasone or bortezomib and dexamethasone, was approved in Japan for treating adults with multiple myeloma whose diseases came back or those whose cancers did not respond to prior therapy.

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