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FDA gives green light for Erbitux in new cancer indication

BMS and Lilly win approval to market the drug for late-stage head and neck cancer

Bristol-Myers Squibb (BMS) and Eli Lilly have won approval in the US to market Erbitux as a treatment for late-stage head and neck cancer, adding to its existing indications in earlier stages of the disease and colon cancer.

First launched in 2006, Erbitux (cetuximab) remains a growth product for both BMS and Lilly as they prepare for life after patent expiries for some of their top-selling products, and the new approval will lend some welcome additional momentum to their oncology franchises.

According to the US National Cancer Institute, head and neck cancers account for 3-5 per cent of all cancers in the US.

The Food and Drug Administration (FDA) has approved Erbitux for use alongside chemotherapy in patients with advanced, metastatic head and neck cancer on the back of a 442-patient trial which showed that the regimen could extend survival compared to one based on chemotherapy alone.

"Erbitux's ability to extend the lives of patients with head and neck cancers is an important tool for oncologists who often rely on a multi-treatment approach for patients," said the FDA's Richard Pazdur, who heads the haematology and oncology products division of the Center for Drug Evaluation and Research.

"Given the aggressive nature of head and neck cancers that cannot be treated with surgery and radiation, it is important that patients have as many treatment options available as possible," he added.

BMS booked $510m in Erbitux sales in the first nine months of the year, a rise of 3 per cent over the same period of 2010, almost all of which came from the US as rights elsewhere are held by Germany's Merck KGaA.

Meanwhile Lilly, whose ImClone unit originally developed the drug, recognises net royalties on Erbitux sales and revenue from manufactured product sold to its marketing partners. The company made $300m from the product in the first nine months of the year.

Lilly and BMS are also in the latter stages of developing Erbitux as a first- and second-line treatment for non-small cell lung cancer and as a first-line therapy for colorectal cancer.

8th November 2011

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