Janssen's Subcutaneous Daratumumab Injection (Darzalex Faspro) Approved in China for Primary Light Chain Amyloidosis

According to the latest announcement from the National Medical Products Administration (NMPA), Janssen’s marketing application for its CD38 monoclonal antibody daratumumab injection (subcutaneous) has been approved in China, with the indication: for the treatment of patients with primary light-chain amyloidosis.

Source: NMPA Official Website

Daratumumab from Janssen Pharmaceuticals is the first fully human monoclonal antibody targeting CD38 to be approved in China. Its intravenous formulation was previously approved in China for monotherapy in adult patients with relapsed and refractory multiple myeloma who have received prior treatment including a proteasome inhibitor and an immunomodulatory agent and demonstrated disease progression on or after their last therapy. In April this year, daratumumab injection received additional approval for use in combination with lenalidomide and dexamethasone, or in combination with bortezomib and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least one prior line of therapy.

Daratumumab subcutaneous injection (brand name: Darzalex Faspro) is a fixed-dose combination of daratumumab and recombinant human hyaluronidase PH20 (rHuPH20). rHuPH20, developed by Halozyme Therapeutics based on the ENHANZE® drug delivery technology, degrades hyaluronic acid in vivo to facilitate the penetration and absorption of subcutaneously administered drugs. Previously, daratumumab subcutaneous injection has been approved by the U.S. FDA for the treatment of multiple myeloma, light chain (AL) amyloidosis, and other indications.

In November 2020, Janssen Pharmaceuticals submitted a marketing authorization application in China for daratumumab injection (for subcutaneous administration). The application was subsequently included in the priority review program by the CDE under the category of "clinically urgently needed shortage drugs, and innovative drugs and improved new drugs for the prevention and treatment of major infectious diseases and rare diseases," and is proposed for the treatment of patients with primary light-chain (AL) amyloidosis.

Based on data from the Phase 3 ANDROMEDA study, which evaluated the efficacy and safety of daratumumab injection (subcutaneous) in combination with bortezomib, cyclophosphamide, and dexamethasone (VCd regimen) compared with the VCd regimen alone, the results showed that the hematologic complete response rate (hemCR) in patients receiving the daratumumab injection (subcutaneous) combination therapy was more than three times that of patients receiving the VCd regimen alone (42% vs 13%).

Managing Editor: Liuli

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