EMA Recommends a Variation to the Terms of Marketing Authorisation for Regorafenib

New indication concerns treatment of patients with unresectable or metastatic GIST who progressed on or are intolerant to imatinib and sunitinib

On 26 June 2014, the European Medicines Agency (EMA) 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 regorafenib (Stivarga). The marketing authorisation holder for this medicinal product is Bayer Pharma AG. They may request a re-examination of the CHMP opinion, provided that they notify the EMA in writing of their intention within 15 days of receipt of the opinion.

The CHMP adopted a new indication as follows:

Treatment of adult patients with unresectable or metastatic gastrointestinal stromal tumours (GIST) who progressed on or are intolerant to prior treatment with imatinib and sunitinib.

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.

For information, the full indications for regorafenib will be as follows:

Stivarga is indicated for the treatment of adult patients with:

  • metastatic colorectal cancer who have been previously treated with, or are not considered candidates for, available therapies. These include fluoropyrimidine based chemotherapy, an anti VEGF therapy and an anti EGFR therapy.
  • unresectable or metastatic GISTs who progressed on or are intolerant to prior treatment with imatinib and sunitinib.