Erbitux receives KFDA approval with prolonged survival by 20 months in patients with head and neck cancer

뉴스 제공

Merck Ltd.

2008-07-14 09:38

Seoul--(뉴스와이어)--Merck Ltd. Korea, the Korean subsidiary of Merck KGaA of Germany, announced that it has been granted approval by KFDA (Korea Food & Drug Administration) for the use of Erbitux in combination with radiotherapy in patients with locally advanced head and neck cancer.

Erbitux is the first targeted therapy for head and neck cancer and has been licensed by FDA since March 2006 and by EMEA (European Medicines Agency) since April 2006 for use in patients with locally advanced head and neck cancer in combination with radiotherapy. In the US, it has been reported as the first drug to be licensed by FDA for locally advanced head and neck cancer in 45 years.

The approval was granted based on a review of the study by Bonner et al. published in 2006 in the NEJM (New England Journal of Medicine). The study reported that Erbitux prolonged survival by 20 months and loco-regional control by 10 months compared to radiotherapy alone. Also, it demonstrated the advantage of maintaining the patient’s quality of life without increasing the adverse events associated with radiotherapy.

“We believe that the approval will set a new paradigm that will change the existing treatment of locally advanced head and neck cancer,” said Young-Joo Kim, head of Merck Serono division of Merck Ltd. Korea. “Erbitux has reported the longest survival among the large Phase III clinical studies conducted so far, and can give a new hope to those patients for whom it has been difficult to provide a cure or prolong survival due to the adverse events of conventional therapies.“

Erbitux has been licensed for the treatment of metastatic colorectal cancer (mCRC) in the second and third-line setting in Europe and the US since February and June 2005 respectively, and has been licensed in Korea by KFDA since June 2005. Currently, Erbitux is prescribed for mCRC patients in 72 countries worldwide, and is licensed for the treatment of head and neck cancer in 66 countries.

Head and neck cancer is the 7th most common cancer in Korea, with over 2500 new cases being diagnosed each year. The top three cancers of the head and neck in the order of incidence are cancers of the larynx, oral cavity, and pharynx. They are over twice more common in males than in females.

웹사이트: http://www.merck.co.kr