Drugs Xagena
The Committee for Medicinal Products for Human Use ( CHMP ) has adopted a positive opinion recommending a variation to the terms of the marketing authorisation for the medicinal product Vectibix.
The CHMP adopted a change to an indication as follows: Vectibix is indicated for the treatment of adult patients with wild-type RAS metastatic colorectal cancer ( mCRC ):
a) in first-line in combination with FOLFOX;
b) in second-line in combination with FOLFIRI for patients who have received first-line fluoropyrimidine-based chemotherapy ( excluding Irinotecan );
c) as monotherapy after failure of fluoropyrimidine-, Oxaliplatin-, and Irinotecan-containing chemotherapy regimens.
The CHMP also adopted a change to a contraindication as follows: the combination of Vectibix with Oxaliplatin-containing chemotherapy is contraindicated for patients with mutant RAS mCRC or for whom RAS mCRC status is unknown.
Vectibix is also contraindicated in patients with a history of severe or life-threatening hypersensitivity to the active substance or to any of the excipients and in patients with interstitial pneumonitis or pulmonary fibrosis. ( Xagena )
Source: European Medicines Agency ( EMA ), 2013
XagenaMedicine_2013
