Amgen receives CHMP recommendation for new Vectibix indication

Amgen has announced that its cancer therapy Vectibix has been recommended for European approval in a new indication.

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has recommended the drug for approval in combination with Folfiri – an irinotecan-based chemotherapy – as a first-line treatment in adult patients with wild-type RAS metastatic colorectal cancer (mCRC).

This recommendation is based on positive safety and efficacy data from the 20060314 study, which evaluated Vectibix plus Folfiri in the first-line setting. Adding Vectibix to chemotherapy was shown to result in better responses than chemotherapy alone.

Colorectal cancer is the third most common cancer worldwide, with about half of the patients with mCRC having wild-type RAS tumours.

Dr Elliott Levy, senior vice-president of global development at Amgen, said: "The CHMP recommendation is an important step toward increasing the treatment options for patients with this aggressive disease and helping improve outcomes in the EU."

This comes after the European Medicines Agency accepted the marketing authorisation application for Amgen's multiple myeloma drug Kyprolis earlier this week.