Colorectal cancer may get another strong enemy this year; Reports
Experts are of the opinion that U.S. Food and Drug Administration (FDA) will approve “Regorafenib”, a medicine developed by Bayer HealthCare that is found to slow down the tumor growth and extended life in advanced cases of colorectal cancer.
Dr. Heinz-Josef Lenz, a professor at USC Keck School of Medicine and an investigator in the regorafenib trial, said alternatives are needed when chemotherapy and other medications become unable to extend the life in people with cancer that has been spread to other parts of the body.
“I think this is a new tool in the armamentarium for patients with this disease,” Lenz said of the findings, reported Tuesday. “In colon cancers, we’ve seen significant changes. Patients who have been treated for years are in good shape, and when they fail one treatment they demand more treatment.”
If the medicine will be approved, it will be the first new treatment for colorectal cancer in more than 5 years.
Prof. Eric van Cutsem, University Hospital Leuven, Belgium, who shares the role of the coordinating investigator of the study, said,
To date regorafenib is the only oral multi-kinase inhibitor as monotherapy that has demonstrated in a large Phase III trial the ability to improve clinical outcomes in patients with advanced refractory colorectal cancer. The data suggest that regorafenib may provide a new standard of care for the treatment of refractory metastatic colorectal cancer.
Researchers have found the following results for the drug regorafenib
• A median OS of 6.4 months compared to 5.0 months for the placebo group (HR=0.77, p=0.0052)
• A median PFS of 1.9 months compared to 1.7 months for the placebo group (HR= 0.49, p<0.000001)
• A DCR of 44.8% compared to 15.3% for the placebo group (p<0.000001)
• An ORR of 1.0% compared to 0.4% for the placebo group (p=0.188)
“We are excited by these results because there is a high unmet medical need for patients with mCRC and these data show that regorafenib could make a positive impact on overall survival in patients who currently have no other options,” said Kemal Malik, MD, Member of the Bayer HealthCare Executive Committee and Head of Global Development. ”We look forward to generating further data for this compound, including results from our other Phase III trial of regorafenib in gastrointestinal stromal tumors”.
Further Reading:
Bayer HealthCare
