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# Janssen Accelerated Approval for Darzalex Faspro
- URL: https://www.fdaweb.com/janssen-accelerated-approval-for-darzalex-faspro/
- Published: 2021-01-19T12:00:00.000Z
- Updated: 2026-09-14T16:43:20.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5148476

FDA has granted accelerated approval to Janssen Biotech’s Darzalex Faspro (daratumumab plus hyaluronidase) for combination use with bortezomib, cyclophosphamide and dexamethasone for newly diagnosed light chain amyloidosis. The approval was based on data from the ANDROMEDA (NCT03201965) trial in 388 patients with measurable disease and at least one affected organ according to consensus criteria, an [FDA release ](https://www.fda.gov/drugs/drug-approvals-and-databases/fda-grants-accelerated-approval-darzalex-faspro-newly-diagnosed-light-chain-amyloidosis?ref=fdaweb.com)says. Patients were randomized to receive bortezomib, cyclophosphamide, and dexamethasone (VCd arm) or with Darzalex Faspro (D-VCd arm). “The hematologic complete response (HemCR) rate based on established consensus response criteria as evaluated by an independent review committee was 42.1% for the D-VCd arm and 13.5% for the VCd arm,” it says.

On the safety side, the approval requires information in the Warnings and Precautions section that serious or fatal cardiac adverse reactions occurred in patients taking the combination therapy. The most common adverse reactions in patients with light chain amyloidosis who received the D-VCd regimen were upper respiratory tract infection, diarrhea, peripheral edema, constipation peripheral sensory neuropathy, fatigue, nausea, insomnia, dyspnea and cough, FDA says.