The European Commission (EC) has approved the Johnson & Johnson company Janssen-Cilag International’s new indication for Darzalex Faspro (daratumumab) subcutaneous (SC) formulation to treat adults with smouldering multiple myeloma (SMM) at high-risk of developing MM.

Daratumumab is co-formulated with Halozyme's drug delivery technology, Enhanze.

The EC approval is based on outcomes from the Phase III AQUILA study, which assessed the safety and efficacy of fixed-duration daratumumab SC administration against active monitoring in patients with high-risk SMM.

The primary endpoint of the study is progression-free survival, while secondary endpoints encompass overall response rate, time to progression and overall survival.

Patients included in the study had been diagnosed with SMM within the previous five years. Those with prior exposure to either approved or investigational treatments for SMM or multiple myeloma were excluded from participation.

Halozyme president and CEO Dr Helen Torley stated: "This approval reinforces DARZALEX Faspro with ENHANZE as a foundational treatment across all stages of multiple myeloma.

"We are pleased that the new treatment paradigm addresses the critical needs of people living with this complex blood disease."

Halozyme's Enhanze drug delivery technology, featuring the enzyme rHuPH20, enables rapid SC delivery of drugs and fluids, enhancing patient experience and reducing treatment burden.

It has been licensed to companies including Takeda, Roche, Pfizer, AbbVie and Acumen Pharmaceuticals.

Johnson & Johnson innovative medicine multiple myeloma disease area leader and vice-president Jordan Schecter stated: “Until now, there have been no approved treatment options for patients diagnosed with high-risk smouldering multiple myeloma.

“We can now offer physicians and patients the option to treat with daratumumab earlier, significantly delaying progression and the need for more intensive, continuous therapy, as well as extending overall survival.”