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Genentech, Biogen Idec, and Roche File Supplemental Biologics License Application for Rituxan in Non-Hodgkin Lymphoma

Strategic Insights

— 1 min read

Genentech, Inc. (DNA), Biogen Idec, Inc. (BIIB), and Roche (SWX) have completed the filing of a supplemental biologics license application (sBLA) with the U.S. Food and Drug Administration (FDA) for an additional indication of Rituxan (Rituximab) in previously untreated patients with intermediate-grade or aggressive, CD-20-positive, B-cell, non-Hodgkin lymphoma (NHL) in combination with CHOP or other anthracycline-based chemotherapy regimens. The application is based on efficacy and safety data from three randomized, controlled, multicenter studies involving 1,854 previously untreated patients with intermediate-grade or aggressive, CD-20-positive, B-cell, NHL. The companies have requested priority review designation from the FDA.

The filing is a significant step towards expanding the use of Rituxan in treating non-Hodgkin's lymphoma. The treatment is currently approved for use in relapsed or refractory, low-grade, or follicular, CD-20-positive, B-cell, NHL. Genentech and Biogen Idec are committed to working closely with the FDA during the review process.

Key Takeaways:

  • The supplemental biologics license application (sBLA) includes efficacy and safety data from three randomized, controlled, multicenter studies involving 1,854 previously untreated patients with intermediate-grade or aggressive, CD-20-positive, B-cell, NHL.
  • The studies evaluated the efficacy endpoint of overall survival and included patients between the ages of 18-60 and 60 years of age or older.
  • The companies have requested priority review designation from the FDA, which could lead to faster approval of the sBLA.
  • Rituxan is currently approved for use in relapsed or refractory, low-grade, or follicular, CD-20-positive, B-cell, NHL.
  • The sBLA filing is a significant step towards expanding the use of Rituxan in treating non-Hodgkin's lymphoma.
  • Genentech and Biogen Idec are committed to working closely with the FDA during the review process.

Statistics:

  • 1,854 previously untreated patients with intermediate-grade or aggressive, CD-20-positive, B-cell, NHL were involved in the three randomized, controlled, multicenter studies.
  • The studies included patients between the ages of 18-60 and 60 years of age or older.
  • Rituxan is currently approved for use in relapsed or refractory, low-grade, or follicular, CD-20-positive, B-cell, NHL.

Sources:

  • Genentech, Inc. (DNA)
  • Biogen Idec, Inc. (BIIB)
  • Roche (SWX)
  • U.S. Food and Drug Administration (FDA)
  • Health & Medicine Week
  • NewsRx.com

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