European Medicines Agency Recommends a Variation to the Terms of the Marketing Authorisation for Panitumumab
Detailed conditions for the use of panitumumab will be available after the variation to the marketing authorisation has been granted by the European Commission
On 27 June 2013, the European Medicines Agency Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a variation to the terms of the marketing authorisation for the medicinal product panitumumab (Vectibix). The marketing authorisation holder for this medicinal product is Amgen Europe B.V. They may request a re-examination of the CHMP opinion, provided that they notify the European Medicines Agency in writing of their intention within 15 days of receipt of the opinion.
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):
- 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)
- 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.
Detailed conditions for the use of this product will be described in the updated summary of product characteristics, which will be published in the revised European public assessment report, and will be available in all official European Union languages after the variation to the marketing authorisation has been granted by the European Commission.