FDA Grants Breakthrough Designation for Pembrolizumab

Expedited FDA Review for CRC Drug This post was compiled and reviewed by Anjee Davis, Andi Dwyer, Nancy Roach and Dr. Tom Marsilje This week the Food and Drug Administration (FDA) granted “Breakthrough Therapy Designation” to Merck’s Keytruda® (pembrolizumab) for patients with MSI-high colorectal cancer….

Read Full Post

Biosimilar Drugs

Some drugs are similar and some are the same: The difference between Brand Name, Biosimilar and Generic There’s an ongoing debate/discussion about if a generic drug is as good as a brand name drug, if a patient has a choice between brand and generic, and when a…

Read Full Post

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…

Read Full Post

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…

Read Full Post

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,…

Read Full Post

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…

Read Full Post

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…

Read Full Post

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…

Read Full Post

Erbitux Approved as First-Line Treatment

The FDA has approved Erbitux™ (cetuximab) in combination with FOLFIRI for first-line treatment of patients with metastatic colorectal cancer whose tumors have a wild-type (WT) KRAS gene.  Erbitux was first approved in 2004 for patients whose cancer was not responding to available treatments. FDA’s action was…

Read Full Post

What Can We Learn from EMILIA?

Written by: Christopher P. Adams, Ph.D.* Chris Adams, one of Fight Colorectal Cancer’s research advocates, shares his thoughts about the results of a large breast cancer trial presented at the 2012 ASCO in Chicago, and aspects of the regulatory process. Thank YOU Chris! On Sunday June…

Read Full Post
Page 1 of 712345...Last »