Drugmaker Bristol-Myers Squibb Co. and partner ImClone Systems Inc. said Thursday that the Food and Drug Administration has granted priority review for their application to sell cancer drug Erbitux as an initial treatment for head and neck cancers.
The drug already is approved for two uses: to treat patients who have advanced head and neck cancer or who have had that cancer recur or spread despite chemotherapy.
A priority review means the FDA will aim to make its decision within six months; a standard review can take up to 12 months.
The new application, which would be for the use of the drug along with chemotherapy, is based on data from a study in 442 patients. According to the companies, in this study patients getting both chemotherapy and Erbitux had a median survival of 10.1 months, compared with 7.4 months for the group getting just chemotherapy.
When it was approved in March 2006, the antibody-based drug was the first new drug for head and neck cancer since the 1950s.