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Johnson & Johnson Files Supplemental Biologics License Application for Myeloma Therapy Candidate
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Johnson & Johnson Files Supplemental Biologics License Application for Myeloma Therapy Candidate
Oct 2, 2024 9:48 PM

04:53 PM EDT, 09/30/2024 (MT Newswires) -- Johnson & Johnson ( JNJ ) said Monday it filed a supplemental biologics license application for Darzalex Faspro in combination with bortezomib, lenalidomide, and dexamethasone for newly diagnosed multiple myeloma patients with deferred autologous stem cell transplant.

This application to the US Food and Drug Administration is supported by data from a phase 3 study, which showed that 60.9% of patients achieved minimal residual disease-negativity with the combination, reducing the risk of progression or death by 43%.

The study compared the efficacy and safety of D-VRd to lenalidomide and dexamethasone in newly diagnosed multiple myeloma patients for whom autologous stem cell transplant is not planned as initial therapy, the company said.

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