FDA advisory committee recommends approval of CT P10 for B Cell Lymphoma (NHL).- Celltrion + Teva.
Celltrion and Teva Pharmaceutical announced the FDA Oncologic Drugs Advisory Committee voted unanimously 16-0 to recommend approval of CT-P10, a proposed monoclonal antibody (mAb) biosimilar to Rituxan1 (rituximab) for the treatment of adult patients in three proposed indications. The proposed indications are: (1) relapsed or refractory, low-grade or follicular, CD20-positive, B-cell Non-Hodgkin�s Lymphoma (NHL) as a single agent; (2) previously untreated follicular, CD20-positive, B-cell NHL in combination with first-line chemotherapy and, in patients achieving a complete or partial response to a rituximab product in combination with chemotherapy, as single-agent maintenance therapy; and (3) non-progressing (including stable disease), low-grade, CD20-positive, B-cell NHL as a single agent after first-line cyclophosphamide, vincristine, and prednisone chemotherapy.
The FDA will take the Committee�s recommendation into consideration before taking action on the Biologics License Application (BLA) for the proposed Rituxan biosimilar. The Committee based its recommendation on a review of a comprehensive data package inclusive of foundational analytical biosimilarity data, nonclinical data, clinical pharmacology, immunogenicity and clinical efficacy and safety data. The results of the clinical development program for CT-P10 demonstrated that there were no clinically meaningful differences between CT-P10 and Rituxan in terms of the safety, purity and potency of the product for the three proposed indications.
Related news and insights
Fabhalta is a Factor B inhibitor that acts proximally in the alternative complement pathway of the immune system, providing comprehensive control of red blood cell (RBC) destruction within and outside the blood vessels (intra- and extravascular hemolysis [IVH and EVH])
Merck KGaA, a leading science and technology company, announced that its two Phase III EVOLUTION clinical trials (evolution RMS 1 and evolution RMS 2) investigating the efficacy and safety of evobrutinib did not meet their primary endpoints of reducing annualized relapse rates (ARR) in people with relapsing multiple sclerosis (RMS) compared to oral teriflunomide (Aubagio) (0.11 vs. 0.11 in evolution RMS 1 and 0.15 for evobrutinib vs. 0.14 for teriflunomide in evolution RMS 2, p=NS in both trials)