Celltrion announced on the 27th that it has received approval from the U.S. Food and Drug Administration (FDA) for the clinical trial application of its biosimilar ‘CT-P44’ of the anticancer drug Darzalex (generic name daratumumab).
The company plans to conduct a comparative study involving a total of 486 patients with refractory or relapsed multiple myeloma in this global clinical trial to prove the similarities in pharmacokinetics, efficacy, and safety between Darzalex and CT-P44. Multiple myeloma is a disease where tumors develop in immune cells within the bone marrow and is the third most common blood cancer worldwide.
Darzalex is a targeted anticancer drug that binds to specific proteins on the surface of multiple myeloma cells, inhibiting the growth of cancer cells. The Danish pharmaceutical company Genmab has licensed the technology to Johnson & Johnson's subsidiary Janssen, which holds the rights for development, production, and sales. The substance patents in the U.S. and Europe are set to expire in 2029 and 2031, respectively. Last year, global sales amounted to approximately $9.744 billion (12.67 trillion won).
Celltrion is expanding its pipeline of anticancer therapies. Recently, it has revealed the results of nonclinical studies for its antibody-drug conjugate (ADC) pipelines, ‘CT-P70’ and ‘CT-P71’, targeting solid tumors such as non-small cell lung cancer and bladder cancer.
A Celltrion official noted, “The new pipeline CT-P44 has received clinical approval in the U.S., the largest anticancer market in the world, and has entered full-scale clinical procedures,” adding, “We will do our best to secure a portfolio of anticancer antibody therapies, including three already proven competitive targeted anticancer drugs, immuno-oncology drugs, and ADC new drugs in the global market.”