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FDA approves new kind of lymphoma treatment. Food and Drug Administration.
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1997
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ImmunologyDrug AccessibilityPharmacotherapyImmunotherapeuticsNew KindImmunotherapyPreventive MedicineOncologyMetronomic TherapyClinical TrialsChemotherapyMonoclonal AntibodyCancer ResearchLymphoid NeoplasiaHealth PolicyCancer TreatmentPharmacologyRegulatory ApprovalImmune Checkpoint InhibitorLymphoma TreatmentDrug AdministrationMedicine
The Food and Drug Administration (FDA) approved rituximab (Rituxan) for treating patients with relapsed or refractory low-grade or follicular, CD20 positive, B-cell non-Hodgkin's lymphoma. The November 26 action was the first approval of a monoclonal antibody to treat cancers. The drug has not yet been tested in persons with HIV, although trials are now being organized. Rituximab, given in four doses over a 22-day period, works by killing B-cells, and appears to work well in combination with standard chemotherapy. Rituximab may be toxic if used as initial chemotherapy; its use follows other treatments that reduce the tumor burden. The cost of the treatment is about $11,000, and may be covered by some insurance policies. The drug was discovered by IDEC Pharmaceuticals and Genetech, Inc. Genetech has established programs to help patients with reimbursement problems and drug accessibility.