You are here

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

Recent Headlines

Scenesse is new treatment for people with rare, painful light sensitivity disease
Humira, Rituxan top list of drugs that added $5.1 billion to nation's health care bill
Lower court rulings cleared the way for generic versions of the MS drug
Maryland man wins lawsuit that alleges that the company's antipsychotic caused his gynecomastia
Antidepressants, ADHD meds are also used to self-poison
Data show PTC Therapeutics drug preserves lung function
U.S. maintains measles elimination status as NY outbreak ebbs
Study lists steps that could save close to $300 billion a year
While many victims used THC, the cause remains elusive