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 treat locally or regionally advanced squamous cell carcinoma of the head and neck in combination with radiation therapy, and as a single agent for the treatment of patients with recurrent or metastatic of the head and neck for whom prior platinum-based therapy did not work.

According to the American Cancer Society, 87,290 Americans will be diagnosed with head and neck cancer in 2008 and over 13,090 Americans are estimated to die from this disease this year.

Erbitux, a targeted therapy, which attacks cancer cells without damaging the normal cells was approved by the FDA in February 2004, in combination with irinotecan in the treatment of patients with metastatic colorectal cancer who are resistant to irinotecan-based chemotherapy and for use as a single agent in the treatment of patients with metastatic colorectal cancer who are intolerant to irinotecan-based chemotherapy. Last year, Erbitux notched $1.3 billion in global sales.

Imclone is aggressively pursuing further market penetration of Erbitux in the U.S. and Europe through product label expansion in colorectal cancer and head and neck cancer as well as in non-small cell lung cancer. On July 16, Erbitux was approved in Japan to treat patients with advanced or metastatic colorectal cancer.

Erbitux faces competition from Genentech Inc’s Avastin and Amgen Inc.’s colon cancer drug Vectibix. Avastin is approved by the FDA for advanced colorectal cancer, advanced non-squamous, non-small cell lung cancer and metastatic HER2-negative breast cancer. Ongoing Phase 3 trials are exploring the potential of administering Vectibix in combination with chemotherapy for first- and second-line metastatic colorectal cancer, as well as in the head and neck cancer setting.