FDA advisory committee recommends approval of CT-P10 for the treatment of non-Hodgkin lymphoma

The U.S Food and Drug Administration’s (FDA) Oncologic Drug Advisory Committee (ODAC) have unanimously voted 16 to 0 in favor of allowing CT-P10 (Truxima®), a monoclonal antibody (mAb) biosimilar to rituximab (Rituxan®), to be approved for the treatment of patients with non-Hodgkin lymphoma (NHL). The proposed indication for CT-P10 are for patients with relapsed or refractory, low-grade or follicular, CD20-positive, B-cell NHL 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 (including stable disease), low-grade, CD20-positive, B-cell NHL as a single agent after first-line cyclophosphamide, vincristine, and prednisone chemotherapy.

The ODAC discussions were based on the data in a biologics license application (BLA) for CT-P10, which is shown that CT-P10 demonstrated bio-similarity between CT-P10 and rituximab in terms of efficacy, safety, pharmacology, analytical similarity, and immunogenicity.

The BLA for CT-P10 was based on results obtained from two randomized, double-blinded trials (NCT02162771 and NCT02260804). Data from both studies demonstrated that there were no clinically meaningful differences between CT-P10 and rituximab (Rituxan®).