05:58 PM EST, 11/06/2025 (MT Newswires) -- Johnson & Johnson ( JNJ ) said late Thursday the US Food and Drug Administration approved Darzalex Faspro to treat adult patients with high-risk smoldering multiple myeloma.

The approval is based on a phase 3 trial, which assessed the efficacy and safety of the drug, the company said.

The study demonstrated improvement in the primary endpoint of progression-free survival and a lower risk of disease progression to active multiple myeloma or death by 51% compared with active monitoring, according to a statement.

A higher response rate of 63.4% was also observed in patients compared with 2% with active monitoring. Adverse reactions experienced by over 20% of the patients included upper respiratory tract infection, fatigue, diarrhea, rash, and sleep disorder, according to the company.