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Merck KGaA gets Japanese approval for cancer drug
16 Jul 2008
Regulatory Affairs
Merck KGaA says the Japanese authorities have approved the use of Erbitux in certain colorectal cancer (CRC) patients.
The company states marketing authorisation was granted for treating patients with epidermal growth factor receptor-positive, inoperable, advanced or recurrent CRC.
It adds the prevalence of CRC has increased significantly in Japan during the past 50 years and now accounts for around one in seven cancer deaths in the country.
Dr Wolfgang Wein, executive vice-president for oncology at Merck Serono, said: "With the increasing incidence of colorectal cancer in the Japanese population, this approval will bring a much needed new treatment option."
Wayne Paterson, president of Merck Serono Japan, commented that his company is "very pleased" to be able to bring the medicine to Japan.
Earlier this month, Merck KGaA revealed the first patient had been enrolled on to a pivotal phase-three study called Expand, which will assess the use of Erbitux in combination with cisplatin and capecitabine to treat patients with advanced or metastatic gastric adenocarcinoma.
