The U.S. FDA on Thursday granted traditional approval for Darzalex Faspro, an injectable version of the multiple myeloma therapy daratumumab, developed by J&J (JNJ) and Halozyme Therapeutics (HALO), as a front-line option for light chain (AL) amyloidosis, a rare blood cell disorder.
In 2021, the agency granted accelerated approval for Darzalex Faspro as part of a combination regimen for adults with newly diagnosed AL amyloidosis, marking the first and only FDA-approved treatment for this patient population.
The latest decision, based on J&J’s (JNJ ANDROMEDA Phase 3 trial, converts the accelerated approval to a traditional approval, the FDA said in a statement.
The regulator first approved Darzalex Faspro in 2020 and expanded its label to ten indications in multiple myeloma later, most recently for the smoldering asymptomatic form of the disease early this month.