Shenzhen Chipscreen Pharmaceutical Co., Ltd, a biopharmaceutical company based in China, announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its drug Epidaza (chidamide). The drug is indicated for the treatment of treatment-naïve diffuse large B-cell lymphoma (DLBCL) patients with positive MYC and BCL2 expression when used in combination with R-CHOP (rituximab, cyclophosphamide, adriamycin, vincristine, and prednisone). This approval is based on the results of a randomized, double-blind, placebo-controlled, multi-center Phase III study, marking the world’s first Phase III regulatory study for treatment-naïve, MYC/BCL2 dual-expressed DLBCL.
The interim analysis results demonstrated that the combination of chidamide with the standard first-line R-CHOP treatment regimen significantly improved the complete response rate (CRR) and event-free survival (EFS). The safety data from the trial was in line with known risks, with no new significant safety signals identified. These findings were featured in the Late-breaking Abstract (LBA) of the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting.
Chidamide, developed by Chipscreen, is a first-in-class, subtype-selective histone deacetylase inhibitor. It has been commercially available in China for the treatment of peripheral T-cell lymphoma, a rare disease, since December 2014.- Flcube.com
