Janssen's Daratumumab Subcutaneous Injection Nominated for Priority Review in China for Primary Light Chain Amyloidosis

On November 11, the CDE website indicated that Johnson & Johnson’s marketing application for “Daratumumab Injection (for subcutaneous injection)” (Acceptance Number: JXSS200050) was proposed to be included in the priority review program, with the indication being primary light-chain amyloidosis. The rationale for the proposed priority review was that it qualifies as an innovative or improved new drug addressing clinically urgent shortages, major infectious diseases, and rare diseases.

Daratumumab is a humanized, anti-CD38 IgG1 monoclonal antibody developed by Johnson & Johnson. In November 2015, daratumumab received FDA approval for marketing through the priority review pathway. The approved indications are: in combination with lenalidomide and dexamethasone, or with bortezomib and dexamethasone, for the treatment of patients with multiple myeloma who have received at least one prior therapy. In July 2019, it was initially granted conditional approval for marketing in China as a monotherapy for the treatment of adult patients with relapsed or refractory multiple myeloma, under the brand name “Zhaoke”.

On October 21, 2020, the marketing application for daratumumab (JXSS2000019/20) was proposed for inclusion in the priority review and approval program, with the indication being "for the treatment of adult patients with multiple myeloma who have received at least one prior line of therapy, in combination with lenalidomide and dexamethasone or with bortezomib and dexamethasone." Less than a month later, the new indication for primary light-chain amyloidosis was again proposed for inclusion in the priority review program.

Currently, daratumumab has become a core product in Johnson & Johnson’s oncology portfolio. Darzalex has undergone a remarkable evolution, advancing from third- and fourth-line therapy to second-line, and now to first-line treatment, with its performance outlook remaining highly positive. In 2018, Darzalex generated annual sales revenue of $2.025 billion, representing a year-over-year increase of 63%; in 2019, its sales reached $2.998 billion, a 48% increase.

From: Insight Database (http://db.dxy.cn/v5/)

Primary Light-Chain Amyloidosis is a rare disease caused by the deposition of monoclonal immunoglobulin light chains with an antiparallel β-sheet structure in tissues and organs, leading to corresponding organ dysfunction. Commonly affected organs include the heart, kidneys, liver, and peripheral nerves, which can ultimately result in renal insufficiency, cardiac insufficiency, hepatic failure, and coagulation abnormalities. The annual incidence rate is 3–5 per 1,000,000, with a slightly higher incidence in males than in females.

We wish daratumumab a smooth review process, hoping it will soon benefit eligible patients in China by providing them with a competitive new treatment option.