The FDA has approved the first rituximab (Rituxan) biosimilar, CT-P10 (Truxima; rituximab-abbs), for the treatment of adult patients with CD20-positive, B-cell non-Hodgkin lymphoma (NHL) as a single agent or in combination with chemotherapy. This is the first biosimilar approved by the FDA for the treatment of patients with NHL.
CT-P10, which is developed by Celltrion and Teva Pharmaceutical Industries, has approved indications that are equivalent to reference rituximab, which includes: relapsed/refractory, low-grade or follicular lymphoma, CD20-positive B-cell NHL as a single agent; previously untreated follicular lymphoma, 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 or stable low-grade, CD20-positive, B-cell NHL as a single agent after first-line cyclophosphamide, vincristine and prednisone (CVP) chemotherapy.
"The Truxima approval is our third biosimilar approval in the past month," said Scott Gottlieb, MD, FDA Commissioner, in a press release. "The growing pipeline of biosimilars is encouraging. We’re seeing more biosimilar drugs gain market share as this industry matures. We’ll continue to make sure biosimilar medications are evaluated efficiently through a process that makes certain that these new medicines meet the FDA’s rigorous standards for approval."
The approval is based on data that included extensive structural and functional characterization, animal study data, human pharmacokinetic data, clinical immunogenicity data, and other clinical data that demonstrated the similarity of CT-P10 to reference rituximab.
Regarding safety, the most common adverse events with the biosimilar are infusion reactions, fever, lymphopenia, chills, infection, and asthenia. Patients should be monitored for tumor lysis syndrome, cardiac adverse reactions, renal toxicity, and bowel obstruction and perforation.
Additionally, patients should not receive vaccinations while in treatment, and the biosimilar should not be administered to female patients who are pregnant or breastfeeding, the FDA stated in the press release.
Similar to reference rituximab, the CT-P10 label contains a boxed warning regarding increased risks of fatal infusion reactions, severe skin and mouth reactions, hepatitis B virus reactivation, and progressive multifocal leukoencephalopathy, a rare, serious brain infection that can result in severe disability or death.
"As part of the FDA's Biosimilars Action Plan, we’re advancing new policies to make the development of biosimilars more efficient and to enable more opportunities for biosimilar manufacturers to make these products commercially successful and competitive. Our goal is to promote competition that can expand patient access to important medicines," Gottlieb stated in the release.
FDA approves first biosimilar for treatment of adult patients with non-Hodgkin’s lymphoma. FDA. Published November 28, 2018. https://bit.ly/2KD2hOu. Accessed November 28, 2018.
Originally published on OncLive® as “FDA Approves First Biosimilar for Non-Hodgkin Lymphoma”