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Genentech Submits Supplemental Application for Herceptin in Early-Stage Breast Cancer

Strategic Insights

— 2 min read

Genentech's submission of a supplemental biologics license application (sBLA) to the U.S. Food and Drug Administration (FDA) for Herceptin in early-stage, HER2-positive breast cancer is based on a joint interim analysis of over 3000 patients from two phase III trials sponsored by the U.S. National Cancer Institute. The analysis showed a 52% reduction in breast cancer recurrence risk in women treated with Herceptin plus standard adjuvant therapy compared to those receiving standard therapy alone. The study also demonstrated a 49% improvement in overall survival, with 13% of patients treated with Herceptin plus chemotherapy experiencing disease recurrence after 3 years, compared to 25% of those treated with chemotherapy alone.

Key Takeaways:

  • Genentech submitted a supplemental biologics license application (sBLA) to the FDA for Herceptin in early-stage, HER2-positive breast cancer based on a joint interim analysis of over 3000 patients from two phase III trials.
  • The analysis showed a 52% reduction in breast cancer recurrence risk in women treated with Herceptin plus standard adjuvant therapy compared to those receiving standard therapy alone.
  • The study demonstrated a 49% improvement in overall survival, with a 33% reduction in the risk of death.
  • After 3 years, 13% of patients treated with Herceptin plus chemotherapy experienced disease recurrence, compared to 25% of those treated with chemotherapy alone.
  • The benefit of adding Herceptin to chemotherapy was consistent across all clinically important patient subgroups, including age, hormone receptor status, tumor size, and number of positive nodes.
  • Genentech has requested a priority review designation from the FDA, which would require the agency to take action on the application within 6 months.
  • The developer of Herceptin praised the collaborative efforts of U.S. cooperative group researchers and lead investigators, who made the joint analysis of phase III results possible.

Statistics:

  • 52% reduction in breast cancer recurrence risk in women treated with Herceptin plus standard adjuvant therapy compared to those receiving standard therapy alone.
  • 49% improvement in overall survival, with a 33% reduction in the risk of death.
  • 13% of patients treated with Herceptin plus chemotherapy experienced disease recurrence after 3 years, compared to 25% of those treated with chemotherapy alone.
  • Hazard ratio of 0.48 for breast cancer recurrence and 0.67 for overall survival.
  • 3000+ patients participated in the two phase III trials.

Sources:

  • "Genentech, Inc. (DNA) Announces Submission of Supplemental Biologics License Application to FDA for Herceptin in Early-Stage HER2-Positive Breast Cancer." NewsRx.com. Copyright 2006, Health & Medicine Week via NewsRx.com.

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