FDA accepts priority review for new indication of Erbitux – update
Source: www.rttnews.com Author: staff Imclone Systems Inc. and Bristol-Myers Squibb Co. announced that the supplemental biological license application seeking expanded approval of Erbitux for first-line treatment of patients with recurrent or metastatic squamous cell carcinoma of the head and neck has been accepted for priority review by the U.S. Food and Drug Administration. Priority review implies that the FDA will review the application in six months. Erbitux is marketed by ImClone and Bristol-Myers Squibb in the U.S. and by German drug and chemical maker Merck KGaA outside the U.S. Bristol-Myers holds 61% of the North American sales rights to Erbitux, while Merck KGaA owns 90% of the drug's international distribution rights. Under the existing agreement with Bristol-Myers, ImClone receives a distribution fee based on a flat rate of 39% of net sales of Erbitux in North America. The companies had sought expanded approval for Erbitux based on data from the randomized Phase 3 EXTREME (ERBITUX in first-line Treatment of REcurrent or MEtastatic head and neck cancer) study1 investigating the efficacy of Erbitux in combination with platinum-based chemotherapy in the first-line treatment of patients with recurrent or metastatic squamous cell carcinoma of the head and neck. According to the study, which was conducted by Merck KGaA, Erbitux, in combination with platinum-based chemotherapy, resulted in a statistically significant improvement in median overall survival time compared with chemotherapy alone. If approved, metastatic squamous cell carcinoma will be the third U.S. indication for Erbitux in head and neck cancer. Erbitux was initially approved to [...]