New formulation slashes multiple myeloma treatment time

Janssen has announced that the European Commission (EC) has granted marketing authorisation for Darzalex (daratumumab) subcutaneous (SC) formulation for the treatment of adult patients with multiple myeloma (MM).

Daratumumab SC is administered as a fixed dose, which significantly reduces treatment time, from hours to approximately three to five minutes, when compared to daratumumab intravenous (IV) formulation.

In addition, only the first dose of daratumumab SC needs to be administered in an environment where resuscitation facilities are available.

“Multiple myeloma is an incurable blood cancer that is often associated with time-intensive treatment regimens, which can be burdensome for patients and physicians,” said Dr Janusz Krawcyk, Consultant Haematologist in Galway University Hospital and Senior Lecturer in Haematology at National University of Ireland Galway.

He said the approval marked important progress for the oncology community as it meant daratumumab could now be administered in significantly less time, thereby reducing the time patients needed to be in the clinical setting.

“Given the current pressures on our health system, this is timely and welcome news, particularly for immunocompromised myeloma patients,” he added.

The expedited approval, which had been granted less than five weeks after the European Medicines Agency’s Committee for Medicinal Products for Human Use gave a Position Opinion, applies to all current daratumumab indications.

Data supporting the approval show that daratumumab SC demonstrated a consistent overall response rate and a similar safety profile compared with daratumumab IV in patients with relapsed or refractory MM.

In addition, there was a nearly two-thirds reduction in systemic infusion-related reactions for daratumumab SC compared to daratumumab IV (13% vs 35%, respectively).