ImClone and Bristol-Myers Squibb’s cancer drug sBLA wins FDA priority review

The companies have also announced that, as requested, the application has been granted a priority review designation by the FDA. Priority review status indicates that the FDA will aim to complete its review of the supplemental biologics license application (sBLA) within six months.

The sBLA submission is based on data from the randomized Phase III Extreme study 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 (SCCHN).

The study was conducted by Merck KGaA, Darmstadt, Germany, the partner of ImClone for Erbitux outside of North America, and showed that Erbitux, in combination with platinum-based chemotherapy, resulted in a statistically significant improvement in median overall survival time compared with chemotherapy alone.

If approved, this will be the third US indication for Erbitux in head and neck cancer. Erbitux was initially approved to treat locally or regionally advanced SCCHN in combination with radiation therapy, and as a single agent for the treatment of patients with recurrent or metastatic SCCHN for whom prior platinum-based therapy has failed.

Eric Rowinsky, chief medical officer and executive vice president of ImClone, said: “There is a significant need for new therapeutic options in the first-line treatment of patients with head and neck cancer. The granting of a priority review for this sBLA by the FDA underscores this unmet need and is a designation given to drugs that potentially offer a significant therapeutic advance over currently available treatments for serious diseases.”