Johnson & Johnson files for US FDA approval of Darzalex Faspro based quadruplet regimen for newly diagnosed multiple myeloma patients for whom transplant is not planned

Johnson & Johnson

30 September 2024 - Results from CEPHEUS study highlight Darzalex Faspro quadruplet regimen as a potential standard of care in newly diagnosed patients regardless of transplant eligibility.

Johnson & Johnson announced today the submission of a supplemental biologics license application to the US FDA for approval of a new indication for Darzalex Faspro (daratumumab and hyaluronidase-fihj) in combination with bortezomib, lenalidomide and dexamethasone for the treatment of adult patients with newly diagnosed multiple myeloma for whom autologous stem cell transplant (ASCT) is deferred or who are ineligible for ASCT.

Read Johnson & Johnson press release

Michael Wonder

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Michael Wonder

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