FDA Approves Johnson & Johnson's Darzalex Faspro for Newly Diagnosed Light Chain Amyloidosis

Recently, the U.S. Food and Drug Administration (FDA) approved Johnson & Johnson’s Xian Janssen’s Darzalex Faspro for the treatment of newDiagnosisadult patients with light-chain amyloidosis.

Notably, Darzalex Faspro is also the first and only FDA-approved therapy for patients with this indication. This time,FDAApproval for the use of this drug in combination with bortezomib, cyclophosphamide, and dexamethasone.

The approval of this new indication is primarily based on data from the Phase III ANDROMEDA study of Darzalex Faspro. Trial results demonstrated that, compared with the current standard treatment regimen of bortezomib, cyclophosphamide, and dexamethasone (VCd) alone—which yielded a hematologic complete response rate of 13%—the combination regimen of Darzalex plus VCd (D-VCd) more than tripled the hematologic complete response rate to 42%. Furthermore, patients receiving the Darzalex-based combination regimen achieved a higher overall hematologic response rate (92% vs. 77%). Compared with the current standard VCd regimen, the Darzalex-based combination also prolonged major organ progression-free survival (MOD-PFS) and event-free survival (EFS). In this study, the safety profile of the combination regimen was consistent with that of subcutaneous Darzalex or the VCd regimen.

Light-chain amyloidosis is a blood disorder associated with abnormal proteins, in which protein abnormalities in patients lead to degeneration of vital organs (particularly the heart, kidneys, and liver). The company does not recommend in controlledClinical Trialpatients with NYHA Class II, III, or IV heart disease or Mayo Stage IIIb light-chain amyloidosis. Globally, 4,500 people are unfortunately diagnosed with light-chain amyloidosis each year. Approximately one-third of patients see five or more doctors on average before receiving an accurate diagnosis, and 72% of patients are diagnosed more than a year after the onset of initial symptoms. Due to delayed diagnosis, the prognosis for these patients is generally poor.DiagnosisIn the first year, approximately 30% of patients with light-chain amyloidosis die.

Darzalex Faspro was initially developed by Genmab. Last May, the drug was approved for four treatment regimens for multiple myeloma (MM), including for newlyDiagnosispatients with multiple myeloma, transplant-ineligible patients with multiple myeloma, and patients with relapsed or refractory multiple myeloma. Darzalex Faspro, comprising daratumumab and hyaluronidase-fihj, is a new subcutaneous (SC) formulation of Darzalex. Currently, the application for Darzalex Faspro for this indication is also under review by European regulatory authorities.BioonBioon.com）