Corporate Banner
Satellite Banner
Genomics
Scientific Community
 
Become a Member | Sign in
Home>News>This Article
  News
Return

FDA approves genetic test to help some colon cancer patients, physicians considering Erbitux therapy

Published: Tuesday, July 10, 2012
Last Updated: Tuesday, July 10, 2012
Bookmark and Share
Test can help some colorectal cancer (CRC) patients and their doctors determine if the drug Erbitux (cetuximab) would be an effective treatment based on the absence of a gene mutation.

The therascreen KRAS RGQ PCR Kit can provide information about the KRAS gene mutation in patients whose CRC has spread to other parts of their body (metastasized). Studies have found that Eribitux is not effective in those who have the mutation.
 
CRC is the third leading cause of cancer death in the United States. According to the American Cancer Society, there were more than 141,000 new CRC cases in 2011, and nearly 50,000 deaths resulted from CRC.
 
Erbitux targets the epidermal growth factor receptor (EGFR) on the surface of CRC cells. When certain chemicals in the body bind to EGFR, the receptor starts a complex chain of biochemical reactions inside the cell that signals the cancer cell to reproduce. Erbitux blocks EGFR, interrupting a signal to reproduce which can stop the growth of CRC cells. However, when CRC cells have a mutation in the KRAS gene, they continue to reproduce even when Erbitux blocks EGFR.
 
The FDA first approved Erbitux in 2004 to treat EGFR-expressing late-stage colorectal cancer after patients stopped responding to chemotherapy. In 2009, the FDA approved updated recommendations for Erbitux, based on studies that found the drug is not effective in patients whose tumors have a mutated KRAS gene.
 
“This test helps clinicians determine whether this specific treatment is an effective option,” said Alberto Gutierrez, Ph.D., director of the Office of In Vitro Diagnostic Device Evaluation and Safety in the FDA’s Center for Devices and Radiological Health.
 
To support the approval of the test, tumor samples from patients in clinical trials used to support the approval of Erbitux were evaluated. The benefits of Erbitux were limited to patients whose tumors did not have one of the seven KRAS mutations detected by the test.
 
Among those whose tumors did not have a KRAS mutation, median survival was 8.6 months for those receiving Erbitux compared with five months for those who did not. Among patients whose tumors had a KRAS mutation, median survival was similar between those who received Erbitux compared with those who did not (4.8 months and 4.6 months, respectively).
 
The FDA simultaneously approved a new indication for Erbitux for use in combination with FOLFIRI, chemotherapy drugs consisting of irinotecan, 5-fluorouracil, and leucovorin, as a first-line treatment in patients with metastatic CRC who have EGFR-expressing, and KRAS wild-type (no mutations) tumors.
 
Among patients with tumors that did not have one of the seven KRAS mutations, median survival was 23.5 months for those who received Erbitux plus FOLFIRI compared with 19.5 months for those who received FOLFIRI. Among patients whose tumors had a KRAS mutation, median survival was similar between those who received Erbitux compared with those who did not.
 
“The approval of this new Erbitux indication with the concurrent approval of a genetic test provides clear guidance on selecting patients who will optimally benefit,” said Richard Pazdur, M.D., director of the Office of Oncology Drug Products in the FDA’s Center for Drug Evaluation and Research. “Clinical trial data leading to the approval of this new indication supports the recommendation to treat those patients whose colorectal tumors do not have KRAS mutations and to avoid treating those with KRAS mutations.”


Further Information

Join For Free

Access to this exclusive content is for Technology Networks Premium members only.

Join Technology Networks Premium for free access to:

  • Exclusive articles
  • Presentations from international conferences
  • Over 3,200+ scientific posters on ePosters
  • More than 4,700+ scientific videos on LabTube
  • 35 community eNewsletters


Sign In



Forgotten your details? Click Here
If you are not a member you can join here

*Please note: By logging into TechnologyNetworks.com you agree to accept the use of cookies. To find out more about the cookies we use and how to delete them, see our privacy policy.

Related Content

FDA Awards Breakthrough Therapy Designation to Boehringer’s Lung Cancer Candidate
Boehringer Ingelheim Pharmaceuticals has scored FDA breakthrough therapy designation for its candidate to treat patients with T790M mutation-positive non-small cell lung cancer.
Wednesday, January 06, 2016
FDA OK’s AquAdvantage Salmon
After an exhaustive and rigorous scientific review, FDA has arrived at the decision that AquAdvantage salmon is as safe to eat as any non-genetically engineered (GE) Atlantic salmon, and also as nutritious.
Monday, November 23, 2015
Advancing Precision Medicine by Enabling a Collaborative Informatics Community
The FDA is developing an informatics platform that will facilitate the sharing of expertise of knowledge in the field of precision medicine.
Wednesday, August 12, 2015
FDA Approves New Orphan Drug for Chronic Myelogenous Leukemia
The U.S. Food and Drug Administration has approved Bosulif (bosutinib) to treat CML, a blood and bone marrow disease that usually affects older adults.
Tuesday, September 11, 2012
Confusion as FDA Classify Genome Interpretation as Medical Test
FDA conclude deciphering your genome should therefore be subject to approval by the appropriate regulatory bodies
Monday, November 28, 2011
Scientific News
Benchtop Automation Trends
Gain a better understanding of current interest in and future deployment of benchtop automated systems.
New Cancer Drug Target Found in Dual-Function Protein
Findings from a study from TSRI have shown that targeting a protein called GlyRS might help to halt cancer growth.
Alzheimer's Genetics Point To New Research Direction
A University of Adelaide analysis of genetic mutations which cause early-onset Alzheimer’s disease suggests a new focus for research into the causes of the disease.
Contagious Cancers Are Spreading in Shellfish
Direct transmission of cancer among some marine animals may be more common than once thought, suggests a new study published in Nature by researchers at Columbia University Medical Center (CUMC).
Contagious Cancers Are Spreading in Shellfish
Direct transmission of cancer among some marine animals may be more common than once thought, suggests a new study published in Nature by researchers at Columbia University Medical Center (CUMC).
Fix for 3-Billion-Year-Old Genetic Error
Researchers at The University of Texas at Austin have developed a fix that allows RNA to accurately proofread for the first time.
Higher Frequency of Huntington's Disease Mutations Discovered
University of Aberdeen study shows that the gene change that causes Huntington's disease is much more common than previously thought.
Revealing the Genetic Causes of Bowel Cancer
A landmark study has given the most detailed picture yet of the genetics of bowel cancer — the UK's fourth most common cancer.
The Epigenetic Influences of Chronic Pain
Researchers at Drexel University College of Medicine are aiming to identify new molecular mechanisms involved in pain.
Fighting Resistant Blood Cancer Cells
Biologists present new findings on chronic myeloid leukemia and possible therapeutic approaches.
Skyscraper Banner

SELECTBIO Market Reports
Go to LabTube
Go to eposters
 
Access to the latest scientific news
Exclusive articles
Upload and share your posters on ePosters
Latest presentations and webinars
View a library of 1,800+ scientific and medical posters
3,200+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
4,700+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FOR FREE!