Healthcare solutions company Johnson & Johnson (NYSE: JNJ) announced on Friday that it has submitted applications to the US FDA and European Medicines Agency for approval of DARZALEX FASPRO (daratumumab and hyaluronidase-fihj) as a subcutaneous monotherapy for high-risk smoldering multiple myeloma.

If approved, DARZALEX FASPRO will be the first treatment to address this precursor stage of active multiple myeloma, aiming to intervene before symptom onset and organ damage.

Supporting data comes from the Phase 3 AQUILA study (NCT03301220), assessing DARZALEX FASPRO against active monitoring. The study's primary focus is progression-free survival, involving 390 patients diagnosed within the past five years without prior treatment exposure.

Results will be presented at the 2024 ASH Annual Meeting in San Diego from 7-10 December.

Smoldering multiple myeloma, detected in 15% of newly diagnosed cases, often progresses to active disease within two years. DARZALEX FASPRO, approved in 2020, has nine indications for multiple myeloma treatment.

DARZALEX, launched in 2015, is the first CD38-directed antibody for multiple myeloma, utilised globally in over 518,000 patients.