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Genmab: Darzalex Approved In Japan For Frontline Multiple Myeloma

Denmark-based Genmab A/S (GMXAY.PK) announced Thursday that the Japanese Ministry of Health, Labor and Welfare or MHLW has approved the use of Darzalex (daratumumab) to treat frontline multiple myeloma.

Darzalex is approved in combination with bortezomib, melphalan and prednisone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant or ASCT.

Darzalex is being developed by Janssen Biotech, Inc. under an exclusive worldwide license agreement. In the deal, Genmab will receive a $7 million milestone payment from Janssen in connection with the approval and first commercial sale of DARZALEX under the newly expanded label. The approval and related milestone do not impact the financial guidance issued by Genmab on August 14, 2019.

The approval is based on data from the Phase III ALCYONE study that showed a reduction of the risk of disease progression or death by 50 percent in newly diagnosed ASCT ineligible multiple myeloma patients.

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