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First Rituximab Biosimilar for Non-Hodgkin Lymphoma Approved by FDA

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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:

  • Relapsed or refractory, low-grade or follicular, CD20-positive B-cell non-Hodgkin lymphoma as a single agent
  • Previously untreated follicular, CD20-positive, B-cell non-Hodgkin lymphoma 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
  • Nonprogressing (including stable disease), low-grade, CD20­-positive, B-cell non-Hodgkin lymphoma as a single agent after first-line chemotherapy with cyclophosphamide, vincristine, and prednisone.

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®.


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