FDA Receives Application Seeking Approval of Darzalex Faspro in ...
2 days ago · An application has been submitted to the Food and Drug Administration (FDA) seeking the approval of Darzalex Faspro (daratumumab and hyaluronidase-fihj) for the treatment of adults with high-risk smoldering multiple myeloma. The application submission was announced in a press release from Johnson & Johnson, the manufacturer of Darzalex Faspro.
J&J bids to add smouldering myeloma to Darzalex label
3 days ago · At the data cutoff point, 33.0% of patients in the Darzalex Faspro group and 52.0% of the active monitoring group had started first-line treatment for multiple myeloma.
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6 days ago · If approved, DARZALEX FASPRO ® will become the first treatment option for patients with smoldering multiple myeloma at high-risk of developing multiple myeloma, offering a novel approach to treat before the onset of active disease and the occurrence of end organ damage . RARITAN, N.J., Nov. 8, 2024 /PRNewswire/ -- Johnson & Johnson (NYSE:JNJ) today announced the submission of regulatory ...
Daratumumab Plus Standard Therapy for Multiple Myeloma
Jan 19, 2024 · A large clinical trial found that adding daratumumab (Darzalex), a targeted cancer drug, to a standard regimen improved outcomes for people with newly diagnosed multiple myeloma. Daratumumab was given as subcutaneous injections and reduced the risk of cancer progression or death by 60%.
DARZALEX® (daratumumab)-based maintenance regimens show …
Sep 27, 2024 · Johnson Johnson (NYSE: JNJ) today announced data from three studies highlighting clinical efficacy of DARZALEX ® (daratumumab) and DARZALEX FASPRO ® (daratumumab and hyaluronidase-fihj) in maintenance regimens.
DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) …
Dec 12, 2023 · DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) received U.S. FDA approval in May 2020 and is approved for eight indications in multiple myeloma, three of which are for frontline treatment...
Janssen Presents Efficacy and Subgroup Analyses from DARZALEX …
NEW ORLEANS, December 12, 2022 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced new analyses from the Phase 3 MAIA study of DARZALEX ® (daratumumab) in combination with lenalidomide and dexamethasone (D-Rd), evaluating progression-free survival (PFS), minimal residual disease (MRD) negativity and …
DARZALEX® (daratumumab) Subcutaneous Formulation-Based
Dec 12, 2023 · European Commission Grants Marketing Authorisation for DARZALEX ® (Daratumumab) Subcutaneous Formulation for All Currently Approved Daratumumab Intravenous Formulation Indications.
U.S. FDA Approves DARZALEX FASPRO® (daratumumab and …
Dec 1, 2021 · DARZALEX FASPRO® is a subcutaneous anti-CD38 monoclonal antibody for multiple myeloma and light chain amyloidosis. It is co-formulated with Halozyme's ENHANZE® drug delivery technology and...
Johnson & Johnson submits applications in the U.S. and EU
5 days ago · DARZALEX (daratumumab) Summary of Product Characteristics. October 2024. ... BioSpace is the digital hub for life science news and jobs. We provide essential insights, opportunities and tools to connect innovative organizations and talented professionals who advance health and quality of life across the globe.