Regulatory Actions
Amgen to Appeal CHMP Opinion on Vectibix (Panitumumab)
Published in Medical Letter on the CDC and FDA, June 17th, 2007
Amgen has received notice from the European Medicines Agency (EMEA) that the European Committee for Medicinal Products for Human Use (CHMP) has adopted a negative opinion for Amgen's marketing authorization application (MAA) for Vectibix(TM) (panitumumab) for patients with metastatic colorectal cancer (mCRC) who have failed chemotherapy.
In accordance with European regulations, Amgen intends to request re-examination of the CHMP opinion through the appeal procedure. Notwithstanding the CHMP's initial view, Amgen is confident that the available data demonstrates that Vectibix improves...
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