Today, the U.S. Food and Drug Administration (FDA) approved rituximab-abbs (Truxima) as the first biosimilar to rituximab (Rituxan) for the treatment of adult patients with CD20-positive, B-cell non-Hodgkin lymphoma to be used as a single agent or in combination with chemotherapy. Rituximab-abbs is the first biosimiliar to be approved in the United States for the treatment of non-Hodgkin lymphoma.
Rituximab-abbs is indicated for the treatment of adult patients with:
The FDA’s approval of rituximab-abbs is based on a review of evidence that included extensive structural and functional characterization, animal data, human pharmacokinetic data, clinical immunogenicity data, and other clinical data that demonstrate rituximab-abbs is biosimilar to rituximab. Rituximab-abbs has been approved as a biosimilar, not as an interchangeable product.
The most common side effects of rituximab-abbs are infusion reactions, fever, lymphopenia, chills, infection, and asthenia. Health-care providers are advised to monitor patients for tumor-lysis syndrome, adverse cardiac reactions, renal toxicity, and bowel obstruction and perforation. Patients should not receive vaccinations while in treatment.
Like rituximab, the labeling for rituximab-abbs contains a boxed warning to alert health-care professionals and patients about increased risks of the following: fatal infusion reactions; severe skin and mouth reactions, some with fatal outcomes; hepatitis B virus reactivation, which may cause serious liver problems including liver failure and death; and progressive multifocal leukoencephalopathy, which can result in severe disability or death.
View the prescribing information for rituximab-abbs.
With the rituximab-abbs approval, the FDA has approved 15 biosimiliars.
The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.