Tag Archives: FDA

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 into the body), stool-based (you test your poo) DNA test designed to analyze the presence of blood and certain DNA mutations in a patient’s stool sample that can indicate cancer and/or precancerous polyps. Cells of DNA are released into the stool continuously as part of the digestive process. There are already at-home screening options

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 screening test that looks for DNA in a patient’s stool that may detect genetic changes associated with cancer cells in the colon or rectum. A positive result from this test would lead patients to diagnostic colonoscopy. In this case, as we commented on new screening technologies we kept the following considerations in mind: 1)

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 meeting with many stakeholders that have an interest in two new potential screening technologies, Epi proColon (by Epigenomics) and Cologuard (by Exact Sciences). Kim Ryan, our Director of Patient Information Services and advocate Marcia Mullins are attending to provide comments as the FDA considers these two new screening technologies.   About Epi proColon & Cologuard

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 discussed questions such as: The potential benefits of CTC for screening  Safety issues related to the use of CTC The role of CTC as one option for screening patients displaying no symptoms of CRC As an organization, we voiced our opinions through formal comments sent before the panel discussion, and submitted verbal comments at

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 into the  FDA’s “fast-track” approval process after the international, multicenter Phase III CORRECT trial  showed improved survival (from 5 to 6.4 months) in all mCRC patients, including those having both non-mutated and mutated KRAS types.

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 cancer got worse despite an initial oxaliplatin-based treatment (e.g. FOLFOX). 

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 prompted by results from a look back at patient outcomes and KRAS status from three trials: CRYSTAL:  phase 3, 1217 patients newly diagnosed with metastatic CRC, comparing FOLFIRI vs FOLFIRI + Erbitux OPUS: phase 2, 337 patients newly diagnosed with metastatic CRC, comparing FOLFOX vs FOLFOX + Erbitux CA225025: phase 3, 572 patients with metastatic CRC that stopped responding to available treatments, comparing Best Supportive

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 3 2012, at the American Society of Clinical Oncology (ASCO) annual meeting in Chicago, Dr Kimberly Blackwell from the Duke Cancer Institute, got on stage in front of over 10,000 doctors, researchers and worldwide media representatives to present initial results from the EMILIA trial.** The trial looked at the safety and effectiveness of a novel drug for a particular type of breast cancer. Despite its

Fake Drugs are a Global Problem

The counterfeit drug trade has reached global proportions, and solving the problem needs a global approach. So says an editorial in this week’s The Lancet. While the Avastin announcement last week raised lots of concern and media attention, the issue of counterfeit drugs isn’t new. In 2009, the European Union seized 34 million fake pills in just two months, including antibiotics, cancer drugs, and sildenafil (Viagra). Counterfeit medicines are a problem for both low and high income countries and can seriously hurt patients. In January the FDA warned healthcare providers not to buy injectable cancer medications from “direct-to-clinic” promotions or non-verified sources. Such drugs, says the FDA, put patients at

FDA Takes Action on Two Critical Cancer Drugs in Shortage

FDA Commissioner Margaret Hamburg announced yesterday during a teleconference that the FDA has arranged to meet critical needs for methotrexate and Doxil® (doxorubicin). FDA has approved temporarily importing Lipodox, which has the same active ingredient — doxorubicin — and the same concentration as Doxil. There should be enough to meet needs for Doxil treatment.  FDA has inspected and approved the foreign plants that manufacture Lipodox. APP Pharmaceuticals and Hospira both have ramped up production of methotrexate. Together they expect to be able to ship the drug immediately and have enough to meet future needs.  Methotrexate is especially needed by children with leukemia where it can produce remissions rapidly and cure

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