Efficacy and safety comparison with original 'Darzalex' in 486 patients
[by Yu, Suin] Celltrion announced on July 3 that its multiple myeloma treatment 'Darzalex' biosimilar 'CT-P44' received approval for a Phase 3 clinical trial plan (IND) from the Ministry of Food and Drug Safety. The approval comes three and a half months after the IND application was submitted on March 20.
In this clinical trial, 온라인 바카라 plans to evaluate and compare the efficacy and safety of Darzalex and CT-P44 over a two-year period in 486 patients with relapsed or refractory multiple myeloma.
The original drug, Darzalex, is a targeted anticancer drug that b온라인 바카라s to a specific protein expressed on the surface of multiple myeloma cells, thereby inhibiting cancer cell growth. As of 2023, global sales of Darzalex reached approximately USD 9.744 billion.
CT-P44 also received approval for a Phase 3 clinical trial IND from the U.S. Food and Drug Administration (FDA) in 2024. 온라인 바카라 aims to accelerate clinical procedures in other major global countries as well.
Conversely, through the clinical development of CT-P44, 온라인 바카라 has expanded its anticancer drug portfolio by introducing a new targeted anticancer drug pipeline. The company plans to actively strengthen its portfolio of anticancer antibody therapies, including immuno-oncology agents and novel antibody-drug conjugates (ADCs), in the future.