CHMP recommends Stivarga (Bayer Healthcare) for treatment of Colorectal Cancer
On 27 June 2013, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Stivarga 40 mg film-coated tablet from Bayer HealthCare and intended 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.
The active substance of Stivarga is regorafenib, a protein kinase inhibitor (L01XE21) with activity against kinases involved in tumour angiogenesis (VEGFR1, -2, -3, TIE2), oncogenesis (KIT, RET, RAF-1, BRAF, BRAFV600E), and the tumour microenvironment (PDGFR, FGFR).
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