Amgen to appeal CHMP opinion on Vectibix
Amgen receives negative opinion for MAA for Vectibix (panitumumab)
Biotech giant 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 (panitumumab) for patients with metastatic colorectal cancer (mCRC) who have failed chemotherapy.
Amgen intends to request re-examination of the CHMP opinion through the appeal procedure.
Amgen believes the available data demonstrates that Vectibix improves progression-free survival (PFS) for mCRC patients who have progressed on, or following fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy regimens.
Vectibix is the first fully human IgG2 monoclonal antibody (MAb) that targets the epidermal growth factor receptor (EGFr), a protein that plays an important role in cancer cell signalling, a well validated target in oncology. The drug was approved by the US FDA in September 2006. The FDA approval of Vectibix was based on a progression-free survival endpoint.
