ImClone Systems yesterday saw a welcome boost to its share price on news that it has filed for US approval of its anticancer drug Erbitux (cetuximab) in head and neck cancer. The submission was delayed in April to allow ImClone more time to analyse data from its pivotal clinical trial [[13/04/05c]], and were given the nod by US regulators in June [[21/06/05b]].
The Phase III study showed 62% of head and neck cancer patients receiving Erbitux plus high-dose radiation were alive after two years of treatment, and 57% survived three years, compared to 55% and 44% respectively of patients receiving radiation alone [[21/06/05b]].
ImClone and partner Bristol-Myers Squibb said they are seeking priority review for Erbitux in combination with radiation for locally-advanced squamous cell head and neck cancer, and as a monotherapy in patients with recurrent or advanced tumours where prior therapy has failed.
Separately, Merck KGaA of Germany said it has also filed for European approval of Erbitux in head and neck cancer.
This expanded indication for Erbitux could prove very healthy for all involved: according to the American Cancer Society, approximately 40,000 Americans will be diagnosed with oral, head and neck cancer this year, including cancers of the tongue, mouth, pharynx, and larynx. No new drug has been approved for head and neck cancer in more than a decade.