FDA gives Bayer’s colon cancer drug “priority”
  • Thu, 06/28/2012 - 2:29pm

The U.S. Food and Drug Administration accepted Bayer’s experimental drug regorafenib for priority review, which could make it marketable in a matter of six months.

According to its website, the FDA assigns priority review status to drugs “that offer advances in treatment, or provide treatment where no adequate therapy exists.” The website also states that the agency devotes more time and resources to priority applications and aims to decrease assessment time from the standard 10 months or longer to six months. That being said, the FDA stresses that even if a drug is labeled a priority, it “does not alter the scientific/medical standard for approval or the quality of evidence necessary” for approval.

Bayer’s regorafenib belongs to a class of drugs called kinase inhibitors. According to MedicineNet, kinase inhibitors decrease the activity of proteins that regulate cell division and growth, stopping tumor development.

Bayer, in partnership with Onyx Pharmaceuticals, hopes to market regorafenib for the treatment of metastic colorectal cancer in patients who have not responded to conventional therapy.

Colorectal cancer, according to MedicineNet, develops when a malignant tumor grows in the inner wall of the large intestine, also called the colon. The cancer can be detected when a specialized doctor examines the inside of the colon during a procedure called a colonoscopy.

According to MedicineNet, colorectal cancer commonly occurs when fleshy growths, called colon polyps, develop in the colon’s lining and become cancerous. Some symptoms of colorectal cancer include:

  • Tiredness and weakness
  • Diarrhea or constipation
  • Bloody stool
  • Stomach pain
  • Narrow stool

Other diseases share the same symptoms as colon cancer, so if you are experiencing these symptoms, please remain calm but consult your physician as soon as possible.





About the Contributor

Jessica Davids
I report on FDA developments and new pharmaceutical launches, risks, and safety concerns.

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