News from Japan: Merck Serono' Erbitux gets extended use; GlaxoSmithKline seeks acquisitions and sees flu vaccine order reduced

Merck Serono, a division of German drug major Merck KGaA says that Erbitux (cetuximab) can now be used in Japan in combination with chemotherapy in the first-line treatment for patients with epidermal growth factor receptor (EGFR)-expressing, curatively unresectable (inoperable), advanced or recurrent colorectal cancer (mCRC) carrying the KRAS wildtype gene. This development is due to a change in the Japanese product information for Erbitux.

'The use of Erbitux as a first-line treatment for colorectal cancer is an important step in increasing the availability of treatment options for Japanese patients in this setting,' said Wolfgang Wein, executive vice president, Oncology, Merck Serono.

The approval of this extended usage for Erbitux was granted following submission of data from the Phase III CRYSTALa trial to Japan's Pharmaceutical and Medical Devices Agency (PMDA). Updated data of CRYSTAL were presented at the American Society of Clinical Oncology's 2010 Gastrointestinal Cancers Symposium (ASCO-GI) supporting the value of Erbitux in the first-line therapy of mCRC patients with KRAS wild-type tumors. They demonstrated a significant overall survival advantage for patients who were treated with Erbitux in combination with FOLFIRI compared to those who received chemotherapy alone.