FDA Okays Adjuvant Trastuzumab (Herceptin) as Monotherapy

By Peggy Peck
SOUTH SAN FRANCISCO, Jan. 21 -- The FDA has given trastuzumab (Herceptin) the additional indication of adjuvant monotherapy for early-stage HER2-positive breast cancer, Genentech announced here.
The company said the FDA decision was predicated on one-year data from the HERA (HERceptin Adjuvant) trial. It found a significant 46% reduction in recurrence among women who took trastuzumab for 52 weeks following multimodality anthracycline-based therapy compared with controls.
The HERA trial also reported a significant increase in disease-free survival among women who received adjuvant therapy with trastuzumab.
Trastuzumab was, however, associated with a higher rate of congestive heart failure -- 2% versus 0.3% in the control group.
Serious infusion reactions -- including fatal infusion reactions -- and pulmonary toxicity have also been reported with trastuzumab. In most cases symptoms occurred during infusion or within 24 hours of infusion.
Trastuzumab infusion should be interrupted for patients with dyspnea or clinically significant hypotension. Patients should be monitored until signs and symptoms completely resolve. Trastuzumab should be discontinued for infusion reactions manifesting as anaphylaxis, angioedema, interstitial pneumonitis, or acute respiratory distress syndrome.