Celltrion Gains EMA Approval to Amend Phase 3 Trial of Darzalex Biosimilar CT-P44
核心洞察
Celltrion has received European Medicines Agency (搜索) approval to change the Phase 3 clinical trial plan for CT-P44 (搜索), its biosimilar to Johnson & Johnson's Darzalex Faspro.
The global, double-blind, randomized study will enroll 394 patients with relapsed or refractory multiple myeloma (搜索) over two years.
The trial compares subcutaneous CT-P44 (搜索) with the reference product, both given with lenalidomide and dexamethasone, to assess efficacy and safety.
Celltrion has secured simultaneous approval from the European Medicines Agency (搜索) for changes to the Phase 3 clinical trial plan for CT-P44 (搜索), its biosimilar to Johnson & Johnson's multiple myeloma drug Darzalex Faspro. The approval covers both clinical design and site conduct under the revised EU framework, clearing an operational hurdle so the trial can proceed under the updated plan.
The global, double-blind, randomized study will enroll 394 patients with relapsed or refractory multiple myeloma (搜索) over two years. It compares the efficacy and safety of subcutaneous CT-P44 (搜索) against the reference product, in combination with lenalidomide and dexamethasone.
Celltrion aims to use the data to demonstrate biosimilarity and potentially support future marketing authorization, part of its push into the high-value oncology biosimilars segment. The company notes the inherent risks that many clinical-stage drugs do not reach approval.