Amgen receives positive CHMP Vectibix opinion

Amgen has announced that it has received a positive opinion from the European Committee for Medicinal Products for Human Use (CHMP) recommending marketing authorisation of Vectibix (panitumumab) in the European Union as a treatment for refractory metastatic colorectal cancer in patients with non-mutated KRAS genes.

The granting of this opinion is based on a positive benefit and risk assessment of the compound in this patient population, with trial data backing the use of KRAS mutation status as a marker of clinical outcome.

Vectibix is a fully-human IgG2 monoclonal antibody that targets epidermal growth factor receptor, which plays a key role in the signalling of cancer cells.

Willard Dere, senior vice-president and international chief medical officer at Amgen, said: “We are pleased that Vectibix has received a positive opinion for conditional approval so patients in the EU have further treatment options for metastatic colorectal cancer.

“This is an important step forward in personalised cancer care.”

He added that the company is dedicated to identifying, confirming and deploying innovative and clinically relevant biomarkers to help doctors provide patients with suitable treatment for their conditions.

In May 2006, Amgen reported that it would appeal the CHMP decision to not recommend Vectibix as a treatment for metastatic colorectal cancer in patients who have failed chemotherapy treatment.