Johnson & Johnson's CD38 monoclonal antibody subcutaneous injection formulation was approved in China, greatly shortening the administration time

Today, China’s National Food and Drug Administration (NMPA) announced that the listing application for the CD38 monoclonal antibody daratumumab injection (subcutaneous injection) of Johnson & Johnson's Janssen company has been approved in China
.

According to the priority review announcement by the Center for Drug Evaluation (CDE) of the State Drug Administration of China, the application is aimed at the indications: treatment of patients with primary light chain amyloidosis

Treatment of patients with primary light chain amyloidosis can be administered within about 3 to 5 minutes.

Image source: NMPA official website

In China, primary light chain amyloidosis has been included in the "First List of Rare Diseases
.

" This is a rare life-threatening disease

A rare life-threatening disease

Public information shows that Janssen’s daratumumab is the first fully human monoclonal antibody that targets CD38 approved in the world and China.
It has been approved for intravenous injection in China for the treatment of multiple cases.
Patients with myeloma
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Studies have shown that daratumomab can specifically recognize CD38 that is highly expressed on malignant plasma cells of multiple myeloma in a high-affinity manner, and then induce tumor cell death through a variety of immune-mediated mechanisms
.

Although the pathogenesis of immunoglobulin light chain amyloidosis is completely different from that of multiple myeloma , plasma cells that overproduce immunoglobulin light chains also express CD38.

Plasma cells that overproduce immunoglobulin light chains also express CD38.

A fixed-dose compound composed of daratumomab and recombinant human hyaluronidase PH20 (rHuPH20) can degrade hyaluronic acid in the body to help the penetration and absorption of subcutaneously injected drugs.

Include urgently needed clinically needed drugs, innovative drugs and improved new drugs for the prevention and treatment of major infectious diseases and rare diseases

Image source: CDE official website

Based on data from a phase 3 study called ANDROMEDA, the study evaluated daratumomab injection (subcutaneous injection) in combination with bortezomib, cyclophosphamide, and dexamethasone (VCd regimen), and the VCd regimen alone Compared with the efficacy and safety
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The results showed that patients receiving daratumomab injection (subcutaneous injection) combination therapy had a hematological complete response rate (hemCR) that was more than three times that of patients receiving VCd regimen alone (42% vs 13%)

Hematology complete response rate (hemCR) is more than three times that of patients receiving VCd regimen alone (42% vs 13%)

The approval of daratumomab injection (subcutaneous injection) in China means that it will benefit more patients with light chain amyloidosis, and it is hoped that its arrival will benefit more Chinese patients
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.

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Disclaimer: WuXi AppTec's content team focuses on introducing global biomedical health research progress

Reference materials:

[1] On October 11, 2021, the drug approval document pending information is released.

[2] US Food and Drug Administration Approves DARZALEX FASPRO™ (daratumumab and hyaluronidase-fihj), a New Subcutaneous Formulation of Daratumumab in the Treatment of Patients with Multiple Myeloma.

[3] Genmab Announces Positive Topline Results in Phase III ANDROMEDA Study of Daratumumab in Light-chain (AL) Amyloidosis.
Retrieved 2020-05-29.
from http:// 28/2040461/0/en/Genmab-Announces-Positive-Topline-Results-in-Phase-III-ANDROMEDA-Study-of-Daratumumab-in-Light-chain-AL-Amyloidosis.
html

[4] DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) Becomes the First FDA-Approved Treatment for Patients with Newly Diagnosed Light Chain (AL) Amyloidosis.
Retrieved Jan 15.
2021.
from https:// -faspror-daratumumab-and-hyaluronidase-fihj-becomes-first-fda-approved-treatment-patients

[4] DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) Becomes the First FDA-Approved Treatment for Patients with Newly Diagnosed Light Chain (AL) Amyloidosis.
Retrieved Jan 15.
2021.
from https:// -faspror-daratumumab-and-hyaluronidase-fihj-becomes-first-fda-approved-treatment-patients