Merck Serono, the biopharmaceutical division of Merck KGaA, of Darmstadt, Germany, said the European Commission approved the Type II variation to amend the Erbitux (cetuximab) product label, updating the indication for Erbitux to the treatment of patients with RAS wild-type metastatic colorectal cancer (mCRC). The approval follows the positive opinion from the Committee for Medicinal Products for Human Use in November. The approval primarily refers to biomarker data from the OPUS (OxaliPlatin and cetUximab in firSt-line treatment of mCRC) study. In the updated product information, Erbitux will now be indicated for the treatment of patients with EGFR-expressing, RAS wild-type mCRC in combination with irinotecan-based chemotherapy, in first-line combination with FOLFOX, or as a single agent in patients who failed oxaliplatin- and irinotecan-based therapy and are intolerant to irinotecan.
Novo Nordisk A/S, of Bagsvaerd, Denmark, said the FDA approved Tretton, coagulation Factor XIII A-subunit (recombinant), for use in the routine prevention of bleeding in adults and children who have rare clotting disorder congenital Factor XIII A-subunit deficiency. Tretton has orphan drug designation in that indication.