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Rituxan FDA Approval History

Last updated by Judith Stewart, BPharm on Jan 27, 2021.

FDA Approved: Yes (First approved November 26, 1997)
Brand name: Rituxan
Generic name: rituximab
Dosage form: Injection for Intravenous Use
Company: Genentech, Inc.
Treatment for: Chronic Lymphocytic Leukemia, Rheumatoid Arthritis, Non-Hodgkin's Lymphoma, Granulomatosis with Polyangiitis, Microscopic Polyangiitis, Pemphigus

Rituxan (rituximab) is a CD20-directed cytolytic antibody indicated for the treatment of patients with non-Hodgkin's lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis, granulomatosis with polyangiitis, microscopic polyangiitis, and pemphigus vulgaris.

Rituxan is indicated for the treatment of:

  • Non-Hodgkin’s Lymphoma (NHL) in adult patients with:
    • relapsed or refractory, low grade or follicular, CD20-positive Bcell NHL as a single agent.
    • previously untreated follicular, CD20-positive, B-cell NHL 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.
    • non-progressing (including stable disease), low-grade, CD20-positive, B-cell NHL as a single agent after first-line cyclophosphamide, vincristine, and prednisone (CVP) chemotherapy.
    • previously untreated diffuse large B-cell, CD20-positive NHL in combination with (cyclophosphamide, doxorubicin, vincristine, and prednisone) (CHOP) or other anthracycline-based chemotherapy regimens.
  • Chronic Lymphocytic Leukemia (CLL) in adult patients with:
    • previously untreated and previously treated CD20-positive CLL in combination with fludarabine and cyclophosphamide (FC).
  • Rheumatoid Arthritis (RA) in adult patients with:
    • moderately-to severely-active RA, in combination with methotrexate, and an inadequate response to one or more TNF antagonist therapies.
  • Granulomatosis with Polyangiitis (GPA) (Wegener’s Granulomatosis) and Microscopic Polyangiitis (MPA) in adult and pediatric patients 2 years of age and older
    • in combination with glucocorticoids.
  • Pemphigus Vulgaris (PV) in adult patients.

Development timeline for Rituxan

Sep 27, 2019Approval FDA Approves Rituxan (rituximab) for Granulomatosis with Polyangiitis (GPA) and Microscopic Polyangiitis (MPA) in Children
Aug 27, 2018Approval FDA Approves Imbruvica (ibrutinib) Plus Rituximab for Patients with Waldenström’s Macroglobulinemia
Jun  7, 2018Approval FDA Approves Genentech’s Rituxan (rituximab) for Pemphigus Vulgaris
Apr 20, 2011Approval FDA Approves Rituxan to Treat Two Rare Disorders
Jan 31, 2011Approval FDA Approves Rituxan for First-Line Maintenance Use in Follicular Lymphoma
Feb 19, 2010Approval FDA Approves Rituxan to Treat Chronic Lymphocytic Leukemia
Feb 28, 2006Approval FDA Approves Rituxan - The First Targeted B-Cell Therapy for Treatment of Moderate-to-Severe Rheumatoid Arthritis
Feb 10, 2006Approval FDA Approves Rituxan Plus CHOP or other Anthracycline-Based Chemotherapy Regimens for First-Line Treatment of Diffuse Large B-Cell Non-Hodgkin's Lymphoma
Nov 26, 1997Approval Rituxan (rituximab) - First New Drug for Non-Hodgkin's Lymphoma in a Decade Receives FDA Clearance for Marketing

Further information

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