Merck KGaA applies to extend Erbitux use

Merck KGaA has submitted an application to the European Medicines Agency to widen the indication of oncology drug Erbitux (cetuximab) to include first-line treatment for metastatic colorectal cancer (mCRC) patients.

The firm reports that this application is backed by data from its Crystal study showing the efficacy of the drug in treating these patients, with the trial suggesting that a combination therapy of Erbitux and an irinotecan-based chemotherapy can boost rates of response, resection and progression-free survival.

Merck claims that the results of the 1,200 patient phase III trials of Erbitux plus Folfiri compared to Folfiri alone show that Erbitux is the sole targeted therapy that can boost the chance of curing mCRC through resection.

Dr Wolfgang Wein, senior executive vice-president of oncology at Merck Serono, said: “The positive results we have seen for Erbitux as a first-line therapy are really important.”

He added that – if the indication of the compound is widened as requested – the drug will provide greater hope for patients with mCRC.

Earlier this year, Bristol-Myers Squibb announced an expansion of its previous agreement with ImClone Systems relating to the development and promotion of Erbitux.

Under the terms of the new agreement, the companies agreed to boost their investment in the clinical development of the compound by several hundred million dollars.