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FDA Approves Truxima for Non-Hodgkin’s Lymphoma

First Biosimilar For Adults With CD20-Positive, B-Cell Non-Hodgkin’s Lymphoma

On November 28, the FDA approved Truxima (rituximab-abbs, Celltrion) as the first biosimilar to rituxan (rituximab) for use as a single agent or combined with therapy for adult patients with CD20-positive, B-cell non-Hodgkin’s lymphoma (NHL).

Specifically, rituximab-abbs is indicated for use as a single agent for treating adults with relapsed or refractory, low-grade or follicular, CD20-positive B-cell NHL; in combination with first-line chemotherapy for those who have previously untreated follicular, CD20-positive, B-cell NHL; as single-agent maintenance therapy in patients with a complete or partial response to a rituximab product plus chemotherapy; and as a single agent after first-line cyclophosphamide, vincristine, and prednisone (CVP) chemotherapy for patients with non-progressing, low-grade, CD20­-positive, B-cell NHL.

The most common side effects of rituximab-abbs 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. Pregnant or breastfeeding women should not take rituximab-abbs as it may harm the developing fetus or newborn baby. Patients should not get vaccinations while taking the drug.

Rituximab-abbs carries a boxed warning about increased risks of fatal infusion reactions; severe skin and mouth reactions, some with fatal outcomes; hepatitis B virus reactivation; and progressive multifocal leukoencephalopathy, a rare, serious brain infection that can result in severe disability or death.

Source: Drugs.com, November 28, 2018

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