Daratumumab SC, administered as a fixed-dose, would reduce treatment time compared to daratumumab intravenous (IV) formulation
EC approves Janssen’s DARZALEX SC for Multiple Myeloma. (Credit: Sébastien Bertrand.)
Johnson & Johnson’s pharmaceutical business Janssen has received the European Commission (EC) marketing authorisation for DARZALEX (daratumumab) subcutaneous (SC) formulation to treat multiple myeloma (MM).
The new DARZALEX SC formulation, administered as a fixed-dose, would reduce treatment time from hours to around three to five minutes, than daratumumab intravenous (IV) formulation.
In addition, only the first dose of DARZALEX SC is required to be administered in an environment provided with resuscitation facilities.
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.”
EC approval for DARZALEX is based on data from the Phase 2 PLEIADES and Phase 3 COLUMBA trials
The company said that the regulatory approval covers all current daratumumab indications in frontline and relapsed or refractory settings, and patients currently on daratumumab IV can switch to the SC formulation if they desire.
The EC approval is based on data from the Phase 2 PLEIADES and Phase 3 COLUMBA studies, in which daratumumab SC showed a consistent overall response rate (ORR) and a similar safety profile compared with daratumumab IV in patients with relapsed or refractory MM.
In addition, the studies showed an approximately two-thirds reduction in systemic infusion-related reactions (IRRs) for daratumumab SC compared to daratumumab IV.
Janssen has recently received the US Food and Drug Administration approval for the DARZALEX SC formulation, locally called as DARZALEX FASPRO (daratumumab and hyaluronidase-fihj) for the treatment of MM.
COLUMBA primary investigator Maria-Victoria Mateos said: “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. Given the current health climate, this is timely and welcome news, particularly for immunocompromised patients.”