Policy & Regulation
Janssen Receives FDA Approval of Darzalex Faspro as Treatment for Newly Diagnosed Patients with Light Chain Amyloidosis
18 January 2021 - - US-based healthcare company Johnson and Johnson's (NYSE: JNJ) Janssen Biotech, Inc. business has received US Food and Drug Administration approval of Darzalex Faspro (daratumumab and hyaluronidase-fihj) in combination with bortezomib, cyclophosphamide and dexamethasone (D-VCd) for the treatment of adult patients with newly diagnosed light chain amyloidosis, US-based biopharmaceutical company Halozyme Therapeutics, Inc. (NASDAQ: HALO) said.

Darzalex Faspro is the first and only FDA-approved treatment for patients with this rare and serious blood disorder associated with the production of an abnormal protein which leads to the deterioration of vital organs, most notably the heart, kidneys and liver.

This indication is approved under accelerated approval and is based on the combination's hematologic complete response rate (hemCR) measure.

Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

Darzalex Faspro is not indicated and is not recommended for the treatment of patients with light chain amyloidosis who have NYHA Class IIIB or Class IV cardiac disease or Mayo Stage IIIB outside of controlled clinical trials.

The FDA approval is based on positive results from the Phase 3 ANDROMEDA study, which were recently presented at the American Society of Hematology 2020 annual meeting.

The study evaluated Darzalex Faspro in combination with VCd, compared with VCd alone, a common treatment regimen offered to adult patients with newly diagnosed AL amyloidosis. 

Patients receiving treatment with Darzalex Faspro experienced a hemCR more than triple that of patients receiving VCd alone (42 % for D-VCd and 13 % for VCd; P