J&J Files sBLA for Darzalex Faspro

Johnson & Johnson has submitted a supplemental BLA for Darzalex Faspro (daratumumab and hyaluronidase-fihj) for a new indication — combination use with bortezomib, lenalidomide and dexamethasone (D-VRd) for treating adults with newly diagnosed multiple myeloma for whom autologous stem cell transplant is deferred or not appropriate.

The filing is based on data from the Phase 3 CEPHEUS study (NCT03652064), which showed 60.9% of treated patients achieved minimal residual disease-negativity with D-VRd and the risk of progression or death was reduced by 43%, according to the company. The study also showed that D-VRd significantly reduced the risk of progression or death by 43% vs VRd, and reached an overall complete response rate of 81.2% with D-VRd vs 61.6% with VRd.

Darzalex Faspro received initial approval 5/2020, and is currently approved for nine indications in multiple myeloma, four of which are for frontline treatment in newly diagnosed patients who are transplant eligible or ineligible.