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The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending approval for daratumumab (Darzalex®) subcutaneous (SC) formulation for the treatment of adult patients with myeloma in frontline and relapsed/refractory settings.

The novel subcutaneous formulation of daratumumab is co-formulated with recombinant human hyaluronidase PH20 (rHuPH20) and reduces treatment time from hours to approximately three to five minutes, with similar efficacy, and fewer infusion-related reactions compared to intravenous (IV) administration. The CHMP’s Positive Opinion for daratumumab SC formulation applies to all current daratumumab indications including newly diagnosed and transplant-ineligible patients, as well as relapsed or refractory patients.

“Despite therapeutic advances in the treatment of multiple myeloma, the time taken for administration of most intravenous treatments is relatively long and there have been few significant improvements over the years,” said Maria-Victoria Mateos, M.D., Ph.D., COLUMBA primary investigator and Director of the Myeloma Unit at University Hospital of Salamanca-IBSAL, Salamanca, Spain. “The daratumumab subcutaneous formulation has the potential to transform the treatment experience for patients and physicians as it reduces time in the chair from hours to minutes, and, because it is administered as a fixed dose from the first treatment, it reduces preparation time and chances of error by eliminating the need for dose calculations.”

The Positive Opinion is supported by data from the Phase 3 COLUMBA and Phase 2 PLEIADES studies presented at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting and 62nd American Society of Hematology (ASH) Annual Meeting, respectively.


Find here the information issued by EMA.

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