Janssen's Subcutaneous Daratumumab (DARZALEX FASPRO) Approved in China for Primary Light Chain Amyloidosis

Source: PharmaCube Info

Author: Shi Bei

On October 11, the official website of the National Medical Products Administration (NMPA) announced that Johnson & Johnson’s CD38 monoclonal antibody, daratumumab injection (for subcutaneous administration), has been approved for marketing by the NMPA for the treatment of patients with primary light chain amyloidosis. Previously, the marketing authorization application for this drug was granted priority review status by the Center for Drug Evaluation (CDE).

Daratumumab subcutaneous injection is a fixed-dose combination of daratumumab and recombinant human hyaluronidase PH20 (rHuPH20), marketed under the trade name DARZALEX FASPRO. This product has been approved in the United States for the treatment of patients with multiple myeloma and light chain amyloidosis.

Clinical data indicate that, compared with intravenous (IV) formulations, the subcutaneous (SC) formulation demonstrates a similar overall response rate and pharmacokinetic profile, requiring only approximately 3 to 5 minutes for administration, whereas intravenous infusion takes several hours. Additionally, the incidence of administration-related systemic reactions (ARRS) with the subcutaneous formulation is reduced by nearly one-third compared to intravenous administration (13% vs. 34%).

An open-label, randomized, active-controlled trial codenamed ANDROMEDA (NCT03201965) evaluated the efficacy of VCd (bortezomib, cyclophosphamide, and dexamethasone) with or without DARZALEX FASPRO in patients with newly diagnosed light-chain amyloidosis. The results showed that the confirmed hematologic complete response rates (HemCR) were 42% and 13% in the DARZALEX FASPRO-VCd and VCd groups, respectively.

Daratumumab is the first fully human monoclonal antibody targeting CD38 to be approved globally and in China. Its intravenous formulation received conditional approval for marketing in China in July 2019. As a blockbuster product for Janssen, financial reports indicate that global sales of daratumumab reached $4.19 billion in 2020 (+39.8%).

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Henlius’s clinical trial application for its biosimilar daratumumab received tacit approval from the CDE on January 12 this year, with plans to initiate clinical studies for the treatment of multiple myeloma (MM).