Johnson & Johnson Submits Application to FDA for Multiple Myeloma Treatment
By Connor Hart
Johnson & Johnson submitted an application to the Food and Drug Administration for the approval of its treatment of newly diagnosed multiple myeloma, a cancer that affects bone marrow.
The application is for the treatment, called darzalex faspro, to be used in combination with an existing multiple myeloma treatment -- called bortezomib, lenalidomide and dexamethasone -- for adult patients with the disease that are deferred from or eligible for an autologous stem cell transplant, the New Jersey healthcare company said Monday.
Data from a Phase 3 study supports its application, as with the treatment, about 61% of patients achieved minimal residual disease-negativity, and the risk of progression or death was reduced by 43%, according to the company.
Write to Connor Hart at connor.hart@wsj.com
(END) Dow Jones Newswires
September 30, 2024 16:52 ET (20:52 GMT)
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