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This Isn't The Big One: Darzalex Wins US Approval In First-Line Multiple Myeloma

 
• By Eleanor Malone

Janssen Biotech has won FDA approval for Genmab-licensed Darzalex in newly diagnosed multiple myeloma. However, the drug was approved in a combination that is not commonly used in the US. A further label expansion will provide a bigger boost to the anti-CD38 antibody's commercial prospects.

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Clinical Constellation: MAIA combo more relevant to US than ALCYONE trial • Source: Shutterstock

Following a priority review, Johnson & Johnson's Janssen Biotech Inc. has gained supplemental approval in the US for Darzalex (daratumumab) to treat newly diagnosed multiple myeloma patients who are ineligible for autologous stem cell transplant. However, the approval was for a combination of Darzalex with a three-drug regimen known as VMP that is used more commonly in Europe and Japan than the US.

VMP is Velcade (bortezomib), marketed by Takeda Pharmaceutical Co. Ltd. exclusively in the US and partnered in Europe and Japan with Johnson & Johnson), melphalan and prednisone. The...

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