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

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.