FDA approves first rituximab biosimilar to treat lymphoma

On November 28, FDA approved the first rituximab (Rituxan, rituximab) biosimilar, Truxima (rituximab-abbs, Celltrion Inc.) for non-Hodgkin’s lymphoma (NHL). 

Rituximab is a monoclonal antibody against CD20. It is widely used in non-Hodgkin’s lymphoma and can be used in combination with chemotherapy or alone.

The original drug was Roche’s Rituxan (rituximab), which was first approved in the United States in 1997. There are other indications for this product, including treatment of rheumatoid arthritis. 

The new biosimilar is Truxima (Rituximab-abbs) from Celltrion. Specifically, it applies to adult patients:

1) As relapsed or refractory, low grade or follicle, CD20 positive B cell NHL as monotherapy

2) As a previously untreated follicle, CD20 positive, B-cell NHL combined with first-line chemotherapy, and patients who achieved complete or partial response to rituximab combined with chemotherapy, as a single-agent maintenance treatment

3) As first-line cyclophosphamide, vincristine and prednisone (CVP) chemotherapy, non-progressive (including stable disease), low grade, CD20 positive, B cell NHL as a single drug

The precautions for this biosimilar are the same as the original drug, including the risk of infusion reactions, severe skin and oral reactions (some with fatal consequences); hepatitis B virus reactivation and progressive multifocal leukoencephalopathy The FDA noted that the most common side effects are infusion reactions, fever, lymphopenia, chills, infection, and weakness. It is recommended that healthcare providers monitor patients for tumor lysis syndrome, adverse cardiac reactions, nephrotoxicity, intestinal obstruction, and perforation. Patients should not be vaccinated during treatment.

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