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

Strategic Insights

— 1 min read

Genentech, Inc., Biogen Idec, Inc., and Roche announced the filing of a supplemental biologics license application (sBLA) with the U.S. Food and Drug Administration (FDA) for an additional indication of Rituxan in previously untreated patients with intermediate grade or aggressive, CD-20-positive, B-cell, non-Hodgkin lymphoma (NHL) in combination with chemotherapy regimens. The application is based on data from three randomized, controlled, multicenter studies involving 1,854 patients. The companies have requested priority review designation from the FDA for this filing. Rituxan is currently approved for use in relapsed or refractory, low-grade, or follicular, CD-20-positive, B-cell, non-Hodgkin lymphoma.

Key Takeaways:

  • The filing of the sBLA is based on data from three randomized, controlled, multicenter studies of Rituxan in combination with chemotherapy regimens in 1,854 patients with intermediate-grade or aggressive, CD-20-positive, B-cell NHL.
  • The studies included in this filing are ECOG 4494, GELA/LNH 98-5, and MInT (MabThera International Trial M39045), with a total of 632, 399, and 823 patients, respectively.
  • The three trials evaluated the efficacy endpoint of overall survival.
  • The companies have requested priority review designation from the FDA for this filing.
  • Rituxan is currently approved for use in relapsed or refractory, low-grade, or follicular, CD-20-positive, B-cell, non-Hodgkin lymphoma.

Statistics:

  • The three estudies involved a total of 1,854 patients with intermediate-grade or aggressive, CD-20-positive, B-cell NHL.
  • The ECOG 4494 trial involved 632 patients 60 years of age or older with intermediate-grade or aggressive, CD-20-positive, B-cell NHL.
  • The GELA/LNH 98-5 trial involved 399 patients 60 years of age or older with diffuse large B-cell lymphoma.
  • The M39045 (MInT) trial involved 823 patients between the ages of 18-60.

Sources:

  • World Disease Weekly editors from staff and other reports
  • Genentech, Biogen Idec, and Roche press release
  • FDA

Note: The external reference for the source "FDA" is assumed to be the official website of the U.S. Food and Drug Administration, but the exact source is not specified in the original text.

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