ImClone Systems says that, following discussions with the US regulator, it is planning to file for approval of its anti-cancer agent, Erbitux (cetuximab), in the treatment of head and neck cancer some time during the third quarter.
ImClone had originally slated a regulatory filing in this new indication for the end of the second quarter [[21/07/04d]], but said a few months ago that this would be delayed to give it more time to analyse data from a pivotal clinical trial [[13/04/05c]].
The latest news follows on from the release of positive clinical trial data in this new indication earlier this month. According to the results, 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, which ImClone says are significant [[09/06/05b]], [[08/06/04c]]. The dossier will also include data from a Phase II trial conducted by ImClone’s European parter, Merck KGaA, which evaluated the response rate of Erbitux as a single agent in patients with advanced recurrent and/or metastatic head and neck cancer not suitable for further local therapy and who had failed on platinum-based chemotherapy.
Erbitux was approved for the treatment of colorectal cancer early last year [[13/02/04b]], and contributed some $34 million dollars to ImClone’s coffers in royalty revenues from partner Bristol-Myers Squibb in the first quarter of 2005, versus just $7 million last year [[27/04/05c]]. Overall sales for Erbitux were $87 million for B-MS during the three months. And this figure could swell significantly with approval in head and neck cancer – 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. More than 11,000 will die from the disease in 2005.