Darzalex-based quadruplet regimen receives positive CHMP opinion for transplant-eligible patients with newly diagnosed multiple myeloma
Beerse: Janssen-Cilag International NV, a Johnson & Johnson company, has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the approval of a Type II variation for DARZALEX (daratumumab) subcutaneous (SC) formulation. The recommendation is for daratumumab SC in combination with bortezomib, lenalidomide, and dexamethasone (D-VRd), for the treatment of adult patients with newly diagnosed multiple myeloma who are eligible for autologous stem-cell transplant (ASCT). SC formulation was previously approved by the European Commission in June 2020.
“Optimising frontline therapy is crucial in disease control and improving long-term outcomes for patients with newly diagnosed multiple myeloma,” said Edmond Chan, MBChB, M.D. (Res), EMEA Therapeutic Area Lead Haematology, Johnson & Johnson Innovative Medicine. “By incorporating daratumumab SC into this novel quadruplet regimen, we aim to establish a new standard of care for eligible patients, enhancing progression-free survival and transforming the treatment landscape.”
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