EMA Recommends Extensions of Therapeutic Indications for Regorafenib

New indication concerns monotherapy in the treatment of patients with hepatocellular carcinoma who have been previously treated with sorafenib

On 22 June 2017, the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change 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.

The CHMP adopted a new indication as follows:

"Stivarga is indicated as monotherapy for the treatment of adult patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib."

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

"Stivarga is indicated as monotherapy for the treatment of adult patients with

  • metastatic colorectal cancer (CRC) 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 gastrointestinal stromal tumours (GIST) who progressed on or are intolerant to prior treatment with imatinib and sunitinib.
  • hepatocellular carcinoma (HCC) who have been previously treated with sorafenib."

Detailed recommendations 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 a decision on this change to the marketing authorisation has been granted by the European Commission.

Summaries of positive opinion are published without prejudice to the European Commission decision, which will normally be issued 67 days from adoption of the opinion.