Merck Serono seeks first-line use for Erbitux
pharmafile | September 6, 2007 | News story | Sales and Marketing |Â Â ErbituxÂ
Merck Serono has seeking a broader licence for its cancer drug Erbitux in Europe to include use as a first-line treatment for metastatic colorectal cancer.
First approved in Europe in June 2004, the drug has become one of the company's star performers, and a first-line indication would boost its sales considerably.
Sales of the drug are forecast to reach $800 million (600 million euros) in 2007, and blockbuster sales well in excess of $1 billion by 2008 would be assured if the expanded licence is approved.
The submission is supported in part by data from the CRYSTAL study that demonstrates the efficacy of Erbitux as a first-line treatment for metastatic colorectal cancer (mCRC) in combination with irinotecan.
The study suggested that the combination significantly increased progression-free survival, response and resection rates. This means that as well as improving efficacy of first-line chemotherapy, Erbitux is the only targeted therapy to increase the chance of cure through resection.
"The positive results we have seen for Erbitux as a first-line therapy are really important," said Dr Wolfgang Wein, head of Oncology at Merck Serono. "If approved, using Erbitux as a first-line therapy will provide a much greater hope for cure for these patients."
The CRYSTAL trial, a phase III study of Erbitux plus FOLFIRI (irinotecan-based therapy) compared with FOLFIRI alone, met the primary endpoint of significantly increasing median duration of progression-free survival in patients with previously untreated mCRC. Findings from this randomised, controlled trial of almost 1,200 patients were presented at the ASCO congress in June 2007.
If approved, the company expects Erbitux to be available as a first-line treatment by the second half of 2008.
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