Colorectal Cancer News

Bayer’s Regorafenib Now Available through Expanded Access

Bayer's new drug regorafenib is now available through expanded access. Patients whose colorectal cancer has progressed on all standard treatments are eligible to apply.

What is regorafenib?
Regorafenib is a cancer-fighting drug developed by Bayer Healthcare. On October 26, 2011, Bayer Healthcare announced positive results from its Phase III trial of regorafenib (BAY 73-4506).

Regorafenib is taken in pill form and works to block the production of specific proteins necessary for cancer growth. It is designed to treat patients with metastatic colorectal cancer whose cancer has continued to advance after approved standard therapies.

Read our regorafenib FAQ.

What is expanded access?
In the case of regorafenib, expanded access means that Bayer has made the drug available, under certain circumstances, to treat a patient who cannot participate in a controlled clinical trial.

According to ClinicalTrials.gov, clinical trials are conducted before drugs are approved to assess safety and efficacy. However, not all patients qualify for these controlled trials due to health problems, age, etc. For patients who cannot participate in a clinical trial of an investigational drug, but have a serious disease or condition that may benefit from treatment with the drug, FDA regulations enable manufacturers of such drugs to provide those patients access to the drug under certain situations, known as "expanded access." The primary intent of expanded access is to provide treatment for a patient's disease or condition, rather than to collect data about the study drug.

Read more about expanded access.

Who is eligible to receive regorafenib?
Metastatic colorectal cancer patients (stage IV) whose cancer has progressed on all standard treatments may be considered for the regorafenib expanded access program.

The drug is currently available at six sites:

• South Carolina (2)
• Missouri
• Florida
• Iowa
• Michigan

See full criteria and site locations.

Who should I contact to be considered for the expanded access program?
To learn more about the expanded access program, please contact Bayer Clinical Trials at clinical-trials-contact@bayerhealthcare.com.

See the full list of regorafenib study locations.

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