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.