30 April 2020 - New subcutaneous formulation reduces the time taken for patients to receive daratumumab treatment from hours to approximately three to five minutes, with similar efficacy and fewer infusion-related reactions compared to intravenous administration.

The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that the CHMP of the EMA has issued a positive opinion recommending approval for Darzalex (daratumumab) subcutaneous formulation for the treatment of adult patients with multiple myeloma in frontline and relapsed/refractory settings. 

The novel subcutaneous formulation of daratumumab is co-formulated with recombinant human hyaluronidase PH20 (rHuPH20) [Halozyme's Enhanze drug delivery technology] and reduces treatment time from hours to approximately three to five minutes, with similar efficacy, and fewer infusion-related reactions compared to intravenous administration.

The CHMP’s positive opinion for daratumumab subcutaneous formulation applies to all current daratumumab indications including newly diagnosed and transplant-ineligible patients, as well as relapsed or refractory patients.

Read Janssen press release