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 3,100+ scientific posters on ePosters
  • More than 4,500+ 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
World’s Largest Coral Gene Database
‘Genetic toolkit’ will help shed light on which species survive climate change.
Early Genetic Changes in Premalignant Colorectal Tissue Identified
Findings point to drivers of early cancer development, targets for cancer prevention therapies.
Scientists Find Evidence That Cancer Can Arise Changes
Researchers at Rockefeller University have found a mutation that affects the proteins that package DNA without changing the DNA itself can cause a rare form of cancer.
Modified Microalgae Converts Sunlight into Valuable Medicine
A special type of microalgae can soon produce valuable chemicals such as cancer treatment drugs and much more just by harnessing energy from the sun.
Breakthrough Approach to Breast Cancer Treatment
Scripps scientists have designed a drug candidate that decreases growth of breast cancer cells.
Loss Of Y Chromosome Increases Risk Of Alzheimer’s
Men with blood cells that do not carry the Y chromosome are at greater risk of being diagnosed with Alzheimer’s disease. This is in addition to an increased risk of death from other causes, including many cancers. These new findings by researchers at Uppsala University could lead to a simple test to identify those at risk of developing Alzheimer’s disease.
A Guide to CRISPR Gene Activation
A comparison of synthetic gene-activating Cas9 proteins can help guide research and development of therapeutic approaches.
Gene That Lowers Heart Attack Risk Identified
Individuals with a rare twelve-letter deletion from a gene on chromosome 17 have significantly reduced non-HDL cholesterol levels and a 35% lower than average risk of heart disease.
Testing Non-Breast/Ovarian Cancer Genes
Researchers have found that expanding gene panel beyond breast/ovarian cancer genes in these patients does not add any clinical benefit. Instead, testing has produced more questions than answers.
Myeloid-Derived Suppressor Cells Play Role in Tumor Growth
Researchers at Baylor College of Medicine have reported a new mechanism that helps cancer cells engage myeloid-derived suppressor cells.
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
3,100+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
4,500+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FOR FREE!