Celltrion Receives Domestic Approval for Phase 3 Clinical Trial of Multiple Myeloma Treatment

Celltrion announced on July 3 that its biosimilar for the multiple myeloma treatment Darzalex, named CT-P44, has received approval from the Ministry of Food and Drug Safety to proceed with a Phase 3 clinical trial.

Darzalex is a targeted anticancer therapy that binds to a specific protein present on the surface of multiple myeloma cells, thereby inhibiting the growth of cancer cells.

In this clinical trial, Celltrion plans to compare the efficacy and safety of Darzalex and CT-P44 in 486 patients with refractory or relapsed multiple myeloma.

CT-P44 also received approval from the U.S. Food and Drug Administration (FDA) last year to conduct a Phase 3 clinical trial.