The U.S. Food and Drug Administration’s (FDA’s) Oncologic Drugs Advisory Committee (ODAC) unanimously voted to recommend approval for CT-P10, a biosimilar of rituximab. The preliminary recommendation is based on data from two randomized clinical trials that demonstrated no clinically meaningful differences between CT-P10 and its reference product.
In the CT-P10 3.3 trial, 140 patients with advanced follicular lymphoma (FL) received either CT-P10 or rituximab plus cyclophosphamide, vincristine, and prednisone chemotherapy. The objective response rates were 95.7 percent with CT-P10 and 90.0 percent with rituximab, and progression-free survival for both control groups was 31 months (p values not provided).
In the CT-P10 3.4 trial, 258 patients with low tumor-burden FL were given either CT-P10 or rituximab as single agents. The objective response rates were 83.1 percent and 81.3 percent in the CT-P10 and rituximab arms, respectively (p values not provided).
The drug’s manufacturers are requesting full FDA approval for three indications in non-Hodgkin lymphoma. While not bound by the ODAC decision, the agency approves most advisory recommendations.