EC Grants Marketing Authorization for Subcutaneous Formulation of Daratumumab

According to a June 4, 2020 press release, the European Commission (EC) has granted marketing authorization to the Janssen Pharmaceutical Companies of Johnson & Johnson for Darzalex (daratumumab) subcutaneous (SC) formulation to treat adults with multiple myeloma.

The SC formulation of daratumumab is administered as a fixed dose, which allows for a reduction in treatment time compared with the intravenous formulation. Additionally, as the authorization applies to all current indications of intravenous daratumumab in frontline and relapse/refractory settings, patients receiving the intravenous formulation can choose to switch to the SC formulation. The decision by the EC was supported with data from two clinical studies-the Phase II PLEIADES study and the Phase III COLUMBA study.

“Multiple myeloma is an incurable blood cancer that is often associated with time-intensive treatment regimens, which can be burdensome for patients and physicians. Today’s approval marks important progress for the oncology community as it means daratumumab can now be administered in significantly less time, thereby reducing the time patients need to be in the clinical setting,” said Maria-Victoria Mateos, COLUMBA primary investigator and Director of the Myeloma Unit at University Hospital of Salamanca-IBSAL, Salamanca, Spain. “Given the current health climate, this is timely and welcome news, particularly for immunocompromised patients.”

“This new formulation was specifically designed as the next step in enhancing the treatment experience with daratumumab, without compromising on safety or efficacy,” said Patrick Laroche, Haematology Therapy Area Lead, Europe, Middle East, and Africa (EMEA), Janssen-Cilag. “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.” 

Source: Janssen