The European Commission has approved Bayer’s Stivarga for the treatment of adults with metastatic colorectal cancer who have previously been treated with, or are not suitable for, available therapies.
The approval, which follows a positive opinion from the Committee for Medicinal Products for Human Use of the European Medicines Agency in June, is based on the Phase III CORRECT study which showed a statistically significant improvement in overall survival and progression-free survival for Stivarga (regorafenib) compared to placebo in patients whose disease had progressed despite prior treatment.
Eric Van Cutsem of the University of Leuven, Belgium, and lead investigator on CORRECT, noted that currently people with early CRC can have surgery to remove the cancer, preceded or followed by radiotherapy and/or chemotherapy to prevent it coming back. “Yet for many people their disease progresses to other parts of the body, dramatically reducing their chance of being cured,” he said, noting that “the multi-targeted action of Stivarga provides a new option in targeting mCRC”.
Stivarga is already available in the USA and Japan for mCRC and is also approved for gastrointestinal stromal tumours in several countries, including the two aforementioned markets.
The drug is co-promoted in the USA with Onyx Pharmaceuticals, which is in the process of being acquired by Amgen, and Onyx receives royalties from Bayer on all global net sales of Stivarga in oncology.
