Satellite Banner
Technology
Networks
Scientific Communities
 
Become a Member | Sign in
Home>News>This Article
  News
Return

FDA Names Breast Cancer Drug a Breakthrough Therapy

Published: Monday, April 15, 2013
Last Updated: Monday, April 15, 2013
Bookmark and Share
An experimental drug being investigated for the treatment of advanced breast cancer by researchers at UCLA this week received breakthrough therapy designation from the U.S. FDA.

In a clinical trial, patients with advanced breast cancer that was estrogen-receptor positive (ER+) and HER2-negative (HER2-), and who were given palbociclib (PD 0332991, Pfizer Inc.) in addition to the standard anti-estrogen treatment of letrozole had significantly higher progression-free survival — the length of time a patient is on treatment without tumor growth — than patients taking letrozole alone.

Enacted as part of the 2012 FDA Safety and Innovation Act, the breakthrough therapy designation was created by the agency to expedite the development and review of a potential new medicine if it is "intended, alone or in combination with one or more other drugs, to treat a serious of life-threatening disease or condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints."

Dr. Richard S. Finn, associate professor of medicine at the Jonsson Cancer Center, initially reported the phase 2 clinical data supporting the designation in December 2012 at the CTRC-AACR San Antonio Breast Cancer Symposium. The clinical study was built on laboratory work from the Translational Oncology Research Laboratory directed by Dr. Dennis Slamon, professor of medicine at UCLA and director of the Jonsson Cancer Center's Revlon/UCLA Women's Cancer Research Program.

In preclinical work, palbociclib was tested in a panel of human breast cancer cells growing in culture dishes and showed very encouraging activity, specifically against ER+ cancer cells. These preclinical observations were then moved into phase 1 clinical studies. Led by Finn and Slamon at UCLA, the studies were designed to determine the doses and safety of a combination with letrozole, a commonly used drug for ER+ breast cancer.

Once the phase 1 studies were completed, the phase 2 studies were performed in 165 patients with breast cancer with ER+ disease. The drug was designated as a breakthrough therapy by the FDA based on the preliminary analysis of the phase 2 data showing that the median progression-free survival of patients given the palbociclib-letrozole combination was 26.1 months, compared with 7.5 months for those given letrozole alone. Among patients with measurable disease, 45 percent receiving the combination had confirmed responses, compared with 31 percent for letrozole alone, and the clinical benefit rates (tumor shrinkage and/or stable disease for a minimum of six months) were 70 percent for those receiving the combination therapy, versus 44 percent for letrozole only.

"This drug combination demonstrated a dramatic and clinically meaningful effect on progression-free survival in women with ER+ breast cancer," Finn said. "These results confirm the preclinical work we began at the Translational Lab."

Finn and colleagues have initiated a randomized, multicenter, double-blind phase 3 study to evaluate palbociclib combined with letrozole, compared with letrozole alone, as a first-line treatment for post-menopausal patients with ER+, HER2-, locally advanced or metastatic breast cancer. The researchers will continue to work closely with Pfizer and the FDA to better understand the implications of the breakthrough therapy designation with the hope that further study will support potential regulatory submission.

Slamon said the phase 2 study results validate the Translational Laboratory's approach.

"By identifying the correct targets for treatment in the right patient population, we move forward with personalized oncology that we hope will greatly improve the outcomes for this group of breast cancer patients," he said. "These results are as exciting as the initial results we saw for trastuzumab (Herceptin) in HER2+ breast cancers but represent a new approach for a different and larger subset of breast cancers, namely those that are ER+."


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 3,500+ scientific posters on ePosters
  • More Than 5,000+ 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

Genome Sequencing May Help Avert Banana Armageddon
Researchers at the University of California, Davis, and in the Netherlands have discovered how three fungal diseases have evolved into a lethal threat to the world’s bananas.
Friday, August 12, 2016
‘Human-on-a-Chip’ Could Replace Animal Testing
Researchers are developing a “human-on-a-chip,” a miniature external replication of the human body, integrating biology and engineering with a combination of microfluidics and multi-electrode arrays.
Monday, June 13, 2016
Unveiling the Complexity of Mysterious Protein Folding
Imagine trying to reverse engineer a car when all you have is a finished product or a box full of parts — no instructions.
Wednesday, June 01, 2016
Study Identifies How Brain Connects Memories Across Time
UCLA Neuroscientists have boost ability of aging brain to recapture links between related memories.
Tuesday, May 31, 2016
Transcription Factor Isoforms Implicated in Colon Diseases
UC Riverside study explains how distribution of two forms of a transcription factor in the colon influence risk of disease.
Thursday, May 19, 2016
An E.coli Detector May be in Your Hands Soon
Hand-held device that can be used to detect a variety of pathogens—including foodborne pathogens like E. coli—at all stages in the food supply chain, from fields to restaurants may be available soon.
Monday, May 16, 2016
Fructose Alters Hundreds of Brain Genes
UCLA scientists report that diet rich in omega-3 fatty acids can reverse the damage.
Tuesday, April 26, 2016
Study Yields the Key to Effective Personalized Medicine
A team of UCLA bioengineers and surgeons has taken a major step toward making personalized medicine a reality.
Monday, April 11, 2016
Tracking RNA in Live Cells
Technique may open doors to new treatments for many conditions, from cancer to autism.
Friday, March 18, 2016
Cat Stem Cell Therapy Gives Humans Hope
By the time Bob the cat came to the UC Davis veterinary hospital, he had used up most of his nine lives.
Monday, February 08, 2016
Crowdfunding the Fight Against Cancer
From budding social causes to groundbreaking businesses to the next big band, crowdfunding has helped connect countless worthy projects with like-minded people willing to support their efforts, even in small ways. But could crowdfunding help fight cancer?
Monday, February 08, 2016
Toxic Pollutants Found in Fish Across the World's Oceans
Scripps researchers' analysis shows highly variable pollutant concentrations in fish meat.
Friday, January 29, 2016
Key Enzyme in Pierce’s Disease Grapevine Damage Uncovered
UC Davis plant scientists have identified an enzyme that appears to play a key role in the insect-transmitted bacterial infection of grapevines with Pierce’s disease, which annually costs California’s grape and wine industries more than $100 million.
Wednesday, January 13, 2016
Science Magazine Names CRISPR ‘Breakthrough of the Year’
In its year-end issue, the journal Science chose the CRISPR genome-editing technology invented at UC Berkeley 2015’s Breakthrough of the Year.
Monday, December 21, 2015
Genome Sequencing May Save California's Legendary Sugar Pine
The genome of California’s legendary sugar pine, which naturalist John Muir declared to be “king of the conifers” more than a century ago, has been sequenced by a research team led by UC Davis scientists.
Thursday, December 17, 2015
Scientific News
Mass Spec Technology Drives Innovation Across the Biopharma Workflow
With greater resolving power, analytical speed, and accuracy, new mass spectrometry technology and techniques are infiltrating the biopharmaceuticals workflow.
One Step Closer to Precision Medicine for Chronic Lung Disease Sufferers
A study led by University of North Carolina at Chapel Hill, and National Jewish Health, has provided evidence of links between SNPs and known COPD blood protein biomarkers.
A Diversity of Genomes
New DNA from understudied groups reveals modern genetic variation, ancient population shifts.
“Sixth Sense” May Be More Than Just A Feeling
The NIH Study shows that two young patients with a mutation in the PIEZ02 have problems with touch and proprioception, or body awareness.
Gene Could Reduce Female Mosquitoes
Virginia Tech researchers have found a gene that can reduce female mosquitoes over many generations.
Biomolecular Manufacturing ‘On-the-Go’
Wyss Institute team unveils a low-cost, portable method to manufacture biomolecules for a wide range of vaccines, other therapies as well as diagnostics.
Improving Crop Efficiency with CRISPR
New study of CRISPR-Cas9 technology from Virginia Tech shows potential to improve crop efficiency.
Fighting Cancer with Sticky Nanoparticles
Treatment that uses bioadhesive nanoparticles drug carriers proved more effective than conventional treatments for certain cancers.
Stem Cell ‘Heart Patch’ Almost Perfected
Scientists aiming to perfect and test 3D "heart patches" in animal model, last hurdle before human patients.
Fighting Plant Pathogens with RNA
Researchers develop strategy that could lead to environmentally friendly fungicide to fight pathogens.
Scroll Up
Scroll Down
Skyscraper Banner

Skyscraper Banner
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
3,500+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
5,000+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FOR FREE!