Teva, Celltrion announce FDA committee unanimously recommends CT-P10

Celltrion and Teva Pharmaceutical Industries (TEVA) announced the FDA Oncologic Drugs Advisory Committee voted unanimously 16-0 to recommend approval of CT-P10, a proposed monoclonal antibody biosimilar to Rituxan for the treatment of adult patients in three proposed indications. The proposed indications are: relapsed or refractory, low-grade or follicular, CD20-positive, B-cell Non-Hodgkin’s Lymphoma as a single agent; 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 non-progressing, 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 for the proposed Rituxan biosimilar.
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