FDA approves new adjuvant indication for Herceptin

ROCKVILLE, Maryland—The FDA has approved a new indication for Genentech's Herceptin (trastuzumab) as a single agent for the adjuvant treatment of HER2-overexpressing, node-negative (ER/PR-negative or with one high-risk feature) or node-positive breast cancer, following multimodality anthracycline-based therapy.

The approval extends Herceptin's adjuvant label to include its use as a single agent and in patients with early-stage HER2-positive, node-negative disease with one or more high-risk features. The high-risk features for node-negative patients include tumors that are hormone-receptor negative, grade 2-3, or greater than 2 cm in size, and patient age under 35.

The approval was based on 1-year HERA (HERceptin Adjuvant) data which reported a significant reduction in breast cancer recurrence of 46% in women taking Herceptin for 52 weeks with HER2-positive, node-positive or -negative breast cancer, compared with standard therapy alone. Disease-free survival was also significantly improved with Herceptin.

Grade 3-4 adverse events in the Herceptin arm occurred at a rate of less than 1% for all events. Congestive heart failure occurred in 2% of Herceptin patients vs 0.3% of standard therapy patients.