Bayer HealthCare submits approval application for colorectal cancer drug
SOUTH SAN FRANCISCO, Calif. — Two drug makers are looking to win approval for an experimental drug in patients with colorectal cancer that has spread to other parts of the body.
Onyx Pharmaceuticals announced that Bayer HealthCare had submitted a regulatory approval application to the Food and Drug Administration for regorafenib in patients with metastatic colorectal cancer.
The drug is a Bayer compound, and Onyx will receive a royalty based on global net sales of the drug for cancer. The regulatory submission was based on a 760-patient, phase-3 study conducted in North America, Europe, China, Japan and Australia, results of which were presented in January at a symposium of the American Society of Clinical Oncology and will be presented at ASCO's annual meeting in Chicago next month.