Herceptin adds adjuvant breast cancer claim
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Genentech's sBLA for adjuvant use of the breast cancer biologic Herceptin (trastuzumab) clears FDA Nov. 16. The new claim, for the adjuvant (post-surgery) treatment of patients with HER2-overexpressing, node-positive breast cancer as part of a regimen containing doxorubicin, cyclophosphamide and paclitaxel, is based on two National Cancer Institute Phase III studies. A European adjuvant indication approved in May is based on Roche's HERA trial; Genentech plans to file the HERA results, which support a less frequent dosing schedule, with FDA by the first quarter 2007. The approved sBLA was submitted in February and received a priority review (1Pharmaceutical Approvals Monthly March 2006, In Brief); the user fee goal of Aug. 17 was pushed back 90 days to review additional analyses and longer term data requested by the agency...