Trials & Filings

FDA Approves J&J’s DARZALEX in Multiple Myeloma

Results showed that DARZALEX significantly reduced the risk of disease progression or death by 44 percent

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By: Kristin Brooks

Managing Editor, Contract Pharma

The Janssen Pharmaceutical Companies of Johnson & Johnson received approval from the U.S. FDA for DARZALEX (daratumumab) in combination with lenalidomide and dexamethasone (Rd) for the treatment of newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant (ASCT). The approval is based on results from the Phase III study, which showed that DARZALEX-Rd significantly reduced the risk of disease progression or death by 44 percent compared to treatment with Rd alone....

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