Janssen granted US approval for multiple myeloma drug combination

pharmafile | August 21, 2020 | News story | Medical Communications  

The FDA has approved Genmab and Janssen’s Darzalex (daratumumab) as a treatment for relapsed and refractory multiple myeloma, when combined with carfilzomib and dexamethasone, in patients who have previously received between one and three lines of therapy.

Janssen acquired the worldwide license to develop, manufacture and commercialise the drug through an agreement with Genmab in 2012.

This treatment has been approved following the randomised, open-label Phase 3 CANDOR trial that included 436 multiple myeloma patients who had relapsed. They received Darzalex either with the additional drug combination or without, and the drug combo was shown to have hit its primary endpoint of progression-free survival.

Dr Jan van de Winkel, Chief Executive Officer of Genmab, remarked: “We are extremely pleased that multiple myeloma patients in the US will now have yet another treatment option as this is the eighth overall US FDA approval for Darzalex and the fifth in the relapsed/refractory setting. In addition, Darzalex is now the first CD38 antibody approved for use in combination with carfilzomib.”

Multiple myeloma affects 26,000 new patients in America every year. Most patients with the disease have no symptoms at all, and many are diagnosed due to symptoms that include bone problems, low blood counts, calcium elevation, kidney problems or infections.

Conor Kavanagh

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