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Amgen wins expanded European licence for cancer drug Vectibix

EMA approves drug as a primary treatment for colorectal cancer

Amgen's cancer drug Vectibix (panitumumab) has been granted a new indication by European regulators.

Vectibix was already conditionally approved in the EU as a monotherapy for patients no longer on chemotherapy, but its licence has now been widened to include two indications for the treatment of patients with wild-type KRAS metastatic colorectal cancer (mCRC).

Willard Dere, Amgen's senior vice president and international chief medical officer, heralded the decision as “a promising step forward for those patients facing an aggressive disease where limited treatment options are available”.

The decision by the European Medicines Agency (EMA) will allow Amgen to market the drug as a first-line treatment for mCRC, in combination with the FOLFOX chemotherapy regime.

Vectibix was also approved as a second-line treatment in combination with FOLFIRI chemotherapy, for those patients who have already received first-line fluoropyrimidine-based chemotherapy (excluding irinotecan).

The European Commission also revised Vectibix's monotherapy indication to include the drug's use to treat patients with wild-type KRAS mCRC after the failure of fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy regimens.

The approval follows positive results from phase III studies 20050203 (PRIME) and 20050181 ('181), which showed that when added to either FOLFOX or FOLFIRI, Vectibix improved progression-free survival (PFS) for patients with wild-type KRAS (mCRC).

Professor Jean-Yves Douillard, director of Clinical and Translational Research, ICO Centre R Gauducheau in France, said: "This European Commission approval for Vectibix earlier in the treatment continuum marks a welcome and important addition of treatment choice in an area where few targeted agents have shown to be effective when used with chemotherapy.”

Colorectal cancer causes more than 630,000 deaths globally every year and is the second most common type of cancer in women worldwide. Overall it is the third most common cancer after breast and lung.

16th November 2011

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