- The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopts a positive opinion to extend the marketing authorization for Amgen's (AMGN -0.6%) Vectibix (panitumumab) to include combination with the chemotherapy regimen FOLFIRI as first-line treatment of adult patients with wild-type RAS metastatic colorectal cancer (mCRC), which constitutes ~50% of mCRC patients.
- Vectibix is currently cleared Europe for the treatment of adult patients with wild-type RAS mCRC as first-line treatment in combination with the chemo regimen FOLFOX; as second-line treatment in combination with FOLFIRI in patients who have received first-line fluoropyrimidine-based chemotherapy (excluding irinotecan) and as monotherapy after failure of fluoropyrimidine-, oxaliplatin- and irinotecan-containing chemotherapy regimens.
- A final decision from the European Commission usually takes ~60 days.
- Vectibix generated $505M in sales last year.