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Genmab: FDA approves Darzalex for multiple myeloma

(CercleFinance.com) - Denmark's Genmab has said that the US Food and Drug Administration has approved the use of Darzalex as treatment for patients newly diagnosed with multiple myeloma, an incurable blood cancer, who are eligible for stem-cell transplants.


The supplemental filing for this indication was submitted by Genmab's partner, J&J's Janssen, in March 2019. The FDA granted priority review to the drug, with a decision date set as of September 2019.

The FDA's approval concerns the use of Darzalex in combination with bortezomib, thalidomide and dexamethasone (VTd).

In 2012, Genmab granted Janssen an exclusive worldwide license to develop, manufacture and commercialize Darzalex.

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