FDA approves first non-invasive DNA test for colorectal cancer

Big news in the colorectal cancer prevention and screening community yesterday! In a never-before-seen move, the Food & Drug Administration (FDA) and Centers for Medicare & Medicaid Services (CMS) jointly proposed Cologuard as a new option for colorectal cancer screening. What is Cologuard? Cologuard, produced by Exact Sciences, is a non-invasive (not requiring insertion of instruments…  Read More

Clarification: Panel Approves Cologuard (not the FDA)

Fight Colorectal Cancer submitted public comments to the FDA last week regarding new colorectal cancer screening tests, including Cologuard by Exact Sciences and Epi proColon by epigenomics. (Read comments here.) Cologuard Update As a result of the advisory committee meeting, an FDA panel voted 10-0 to recommend that the FDA approve Cologuard. Cologuard is a stool-based…  Read More

Comments on New DNA & Stool-Based Screening Tests to FDA

This week Fight Colorectal Cancer is providing comments to the FDA as they consider two new screening technologies for colorectal cancer. Below are our opinions and recommendations presented to the Molecular and Clinical Genetics Panel as part of the Medical Devices Advisory Committee. Background: This week, the Food & Drug Administration (FDA) is hosting an advisory committee…  Read More

Fight Colorectal Cancer Offers Input on Virtual Colonoscopy to FDA

On Monday, Fight Colorectal Cancer’s director of patient information services, Kim Ryan, attended a discussion panel hosted by the Food & Drug Administration (FDA) focusing on Gastroenterology/Urology and Radiological Devices on Computed Tomography Colonography (CTC). The 26-member panel discussed the risks and benefits of computed tomography colonography (virtual colonoscopy) for patients not experiencing any signs or symptoms of colorectal cancer. The panel…  Read More

FDA Approves Regorafenib for Metastatic CRC

  The FDA today approved the use of the drug regorafenib (brand name Stivarga) for patients whose metastatic colorectal cancer has progressed despite all currently approved treatment regimens. This is the second new drug approved by the FDA recently after a drought of 5 years in approving new treatments for metastatic colorectal cancer (mCRC). Regorafenib was placed…  Read More

Ziv-Aflibercept gets FDA approval

Ziv-Aflibercept Approved as 2nd line treatment for metastatic CRC   For the first time in more than five years, the FDA has approved a new drug for certain patients who have metastatic colorectal cancer. The FDA has approved ZALTRAP® (ziv-aflibercept) to be used with FOLFIRI as a “second-line” treatment for patients with stage IV colorectal cancer whose…  Read More