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Japan approves Genmab's Darzalex in newly diagnosed multiple myeloma

Published on 22/08/19 at 11:38am

Genmab has secured a new approval for its CD38 monoclonal antibody Darzalex (daratumumab), this time in Japan for the treatment of newly diagnosed multiple myeloma in patients who are ineligible for autologous stem cell transplant (ASCT), when used in combination with bortezomib, melphalan and prednisone.

This latest approval means that Darzalex is the first therapy of its kind to secure approval in the United States, Europe and Japan. The decision was made based on Phase 3 data demonstrating that the Darzalex combination improved progression-free survival by 50%.  

Darzalex is being developed within an agreement signed between Genmab and Janssen in 2012, with the former granting the latter exclusive license to develop, manufacture and commercialise the drug worldwide. Genmab is due to receive $7 million in milestone payments from Janssen for the drug’s approval and first sales.

“Multiple myeloma remains one of the most common forms of blood cancer in Japan and as such, we are encouraged that patients in Japan newly diagnosed with this disease now have the option to receive a Darzalex-containing regimen,” said Dr Jan van de Winkel, Chief Executive Officer of Genmab.

Matt Fellows

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