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Regorafenib in the treatment of metastatic colorectal cancer, approved in the European Union


Bayer HealthCare has announced that the European Commission has approved Stivarga ( Regorafenib ) tablets for the treatment of adult patients with metastatic colorectal cancer ( mCRC ) who have previously been treated with, or are not considered candidates for, available therapies.
These include fluoropyrimidine based chemotherapy, an anti-VEGF therapy and an anti-EGFR therapy.

Colorectal cancer is one of the most prevalent cancer types for which there is a real unmet need for new treatment options. Currently people with early colorectal cancer 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.

The approval of Stivarga was based on data from the pivotal Phase III CORRECT ( Colorectal cancer treated with regorafenib or placebo after failure of standard therapy ) trial.
The study results have showed that Regorafenib plus best supporters care ( BSC ) significantly has improved both overall survival ( hazard ratio, HR=0.77, 1-sided p-value=0.0052 ) and progression-free survival ( HR=0.49, 1-sided p-value less than 0.000001 ) compared to placebo plus BSC in patients with mCRC whose disease had progressed after approved standard therapies.
In the study, median overall survival was 6.4 months with Regorafenib versus 5.0 months with placebo; median progression-free survival was 1.9 months with Regorafenib versus 1.7 months with placebo.

In the CORRECT study, the most frequently observed adverse drug reactions ( equally or greater than 30% ) in patients receiving Regorafenib were asthenia/fatigue, decreased appetite and food intake, hand-foot-skin reaction/ palmar-plantar erythrodysesthesia, diarrhea, mucositis, weight loss, infection, hypertension, and dysphonia.

Regorafenib is an oral multi-kinase inhibitor that inhibits various kinases within the mechanisms involved in tumor growth and progression ( angiogenesis, oncogenesis and the tumor microenvironment ).
In preclinical studies, Regorafenib inhibits several angiogenic VEGF receptor tyrosine kinases that play a role in tumor neoangiogenesis. It also inhibits various oncogenic and tumor microenvironment kinases including VEGFR 1-3, KIT, RET, PDGFR, and FGFR, which individually and collectively impact upon tumor growth, formation of a stromal microenvironment and disease progression. ( Xagena )

Source: Bayer HealthCare, 2013

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