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GEN News Highlights : Mar 31, 2011

Amgen to Appeal EMA’s Negative Opinion on Vectibix Combination with Chemotherapy

Firm claims clinical trials demonstrate that combination boosts progression-free survival in wild-type KRAS mCRC.

Amgen has confirmed that it will formally appeal against the European Medicines Agency’s recent recommendation against extending the marketing authorization for Vectibix® (panitumumab) to include combination with chemotherapy for the treatment of patients with wild-type KRAS metastatic colorectal cancer (mCRC).

The firm maintains that clinical trials have clearly shown that adding Vectibix to FOLFOX or FOLFIRI chemotherapy improved progression-free survival when compared with chemotherapy alone in patients with wild-type KRAS mCRC.

Vectibix is already approved in more than 30 countries outside the U.S. as monotherapy for patients with wild-type KRAS mCRC when standard chemotherapy is no longer effective. In the U.S., Vectibix received accelerated approval in September 2006 as a monotherapy for the treatment of patients with EGFR-expressing mCRC after disease progression on or following fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy regimens. In Japan and Israel, Vectibix is approved for use in combination with chemotherapy for patients with wild-type KRAS mCRC.