EU extends approval of Vectibix plus FOLFIRI in wild-type RAS mCRC-Amgen
The committee for medicinal products for human use of the European Medicines Agency has adopted a positive opinion to extend the marketing authorization for Vectibix (panitumumab), from Amgen, to include combination with FOLFIRI (irinotecan-based chemotherapy) as first-line treatment in adult patients with wild-type RAS metastatic colorectal cancer (mCRC).
The new indication is based upon the 20060314 study, which evaluated Vectibix plus FOLFIRI in the first-line setting. The safety profile of Vectibix was consistent with previously reported studies.
Vectibix is already approved in the European Union for the treatment of adult patients with wild-type RAS mCRC1 :in first-line in combination with FOLFOX :in second-line in combination with FOLFIRI for patients who have received first-line fluoropyrimidine-based chemotherapy (excluding irinotecan), and as monotherapy after failure of fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy regimens.
150 mins
Learning Zones
The Learning Zones are an educational resource for healthcare professionals that provide medical information on the epidemiology, pathophysiology and burden of disease, as well as diagnostic techniques and treatment regimens.