Herceptin early adjuvant sBLA
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Genentech is requesting a priority review for its supplemental BLA for use of Herceptin (trastuzumab) in early adjuvant treatment of HER-2 positive breast cancer. Announced Feb. 15, the application includes data from two randomized Phase III trials showing that the addition of Herceptin to standard adjuvant therapy significantly reduced the risk of recurrence (1Pharmaceutical Approvals Monthly May 2005, In Brief)...
You may also be interested in...
Herceptin adds adjuvant breast cancer claim
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...
Herceptin Phase III early adjuvant data
Genentech halts two Phase III trials of Herceptin (trastuzumab) as adjuvant therapy in women with early HER2 positive breast cancer following positive interim results. A preliminary analysis of the National Cancer Institute-sponsored trials found Herceptin provided an improvement in the primary endpoint of disease-free survival as well as the secondary endpoint of overall survival. "We will work…to prepare these data for discussion with the FDA about a filing for Herceptin in the adjuvant setting based on this interim analysis," Genentech said. Novartis is planning an sNDA for use of Femara (letrozole) in the early adjuvant breast cancer setting in the second quarter (1Pharmaceutical Approvals Monthly February 2005, p. 5)...
Cosmetic And Personal Care Trademark Review: 16 April
Personal care and cosmetic product trademark filings compiled from the Official Gazette of the US Patent and Trademark Office, Class 3.