According to Janssen, the subcutaneous formulation of daratumumab is administered as a fixed dose, which considerably brings down treatment time, from hours to nearly three to five minutes, when compared to its intravenous (IV) formulation.
Apart from that, only the first dose of the subcutaneous formulation of the drug needs to be given to patients in an environment where resuscitation facilities are available, said the company.
The EC approval is applicable to all the current indications of the Janssen drug in frontline and relapsed/refractory settings. Furthermore, the approval allows patients who are presently on daratumumab IV treatment to switch to the subcutaneous formulation if they want.
The EC approval for the subcutaneous formulation is supported by the findings of the phase 2 PLEIADES (MMY2040) trial and the phase 3 COLUMBA (MMY3012) trial.
The data showed that daratumumab subcutaneous formulation delivered a consistent overall response rate (ORR) and a similar safety profile compared with the drug’s IV formulation in patients with relapsed or refractory multiple myeloma.
The subcutaneous formulation of the drug is co-formulated with recombinant human hyaluronidase PH20 (rHuPH20).
Janssen-Cilag Europe, Middle East and Africa (EMEA) haematology therapy area lead Patrick Laroche said: “This new formulation was specifically designed as the next step in enhancing the treatment experience with daratumumab, without compromising on safety or efficacy.
“Since its first launch, daratumumab has been used by more than 130,000 patients globally, and Janssen is pleased to expand our offering by making the subcutaneous formulation available for all previously approved indications.”
Recently, Janssen secured approval from the US Food and Drug Administration for the subcutaneous formulation of its multiple myeloma drug, which is marketed in the country as Darzalex Faspro (daratumumab and hyaluronidase-fihj).
Daratumumab has been designed to target CD38, which is believed to be a highly expressed surface protein found across multiple myeloma cells, regardless of disease stage.