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CHMP issues positive opinion on expanded use of Amgen's Vectibix

Feb. 27, 2015 10:48 AM ETAmgen Inc. (AMGN) StockAMGNBy: Douglas W. House, SA News Editor
  • 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.

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