Corporate Banner
Satellite Banner
Genomics
Scientific Community
 
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
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 2,400+ scientific posters on ePosters
  • More than 3,700+ 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

Scientists Create CRISPR/Cas9 Knock-In Mutations in Human T Cells
In a project spearheaded by investigators at UC San Francisco, scientists have devised a new strategy to precisely modify human T cells using the genome-editing system known as CRISPR/Cas9.
Tuesday, July 28, 2015
Engineers Crack DNA Code of Autoimmune Disorders
Researchers have identified an unexpectedly general set of rules that determine which molecules can cause the immune system to become vulnerable to the autoimmune disorders lupus and psoriasis.
Wednesday, June 10, 2015
Genetic Markers for Detecting and Treating Ovarian Cancer
Custom bioinformatics algorithm identifies human mRNAs that distinguish ovarian cancer cells from normal cells and provide new therapeutic targets
Wednesday, May 27, 2015
Industry-Sponsored Academic Inventions Spur Increased Innovation
Analysis questions assumption that corporate support skews science toward inventions that are less useful than those funded by the government or non-profit organizations.
Monday, March 24, 2014
Researchers Change Cell Types by Flipping a Single Switch
New findings have identified a method for changing one cell type into another in a process called forced transdifferentiation.
Friday, December 06, 2013
Scientists Pinpoint Cell Type and Brain Region Affected by Gene Mutations in Autism
UCSF-led study zeroes in on when and where disrupted genes exert effects.
Tuesday, November 26, 2013
Digging Deeper Into Cancer
What a pathologist looks for in a Pap test sample, but hopes not to find, are oddly shaped cells with abnormally large nuclei. The same is true for prostate and lung cancer biopsies.
Tuesday, November 19, 2013
Nanotech Method Show Promise Against Pancreatic Cancer
Researchers at UCLA's Jonsson Comprehensive Cancer Center have developed a new technique for fighting deadly and hard-to-treat pancreatic cancer.
Monday, November 18, 2013
Researchers Un-Junking Junk DNA
A study shines a new light on molecular tools our cells use to govern regulated gene expression.
Wednesday, November 13, 2013
Fast-Mutating DNA Sequences Shape Early Development
What does it mean to be human? According to scientists the key lies, ultimately, in the billions of lines of genetic code that comprise the human genome.
Wednesday, November 13, 2013
Did Inefficient Cellular Machinery Evolve to Fight Viruses and Jumping Genes?
UCSF scientist poses new theory on origins of eukaryotic gene expression.
Monday, November 11, 2013
Powerful Anti-Cancer Compound Safely Delivered
Researchers have discovered a way to effectively deliver staurosporine (STS).
Tuesday, October 22, 2013
New Insights into How Proteins Regulate Genes
Researchers have developed a new way to parse and understand how special proteins called "master regulators" read the genome, and consequently turn genes on and off.
Monday, October 21, 2013
Cell Growth Discovery Has Implications for Targeting Cancer
The way cells divide to form new cells is controlled in previously unsuspected ways.
Monday, October 21, 2013
Single Gene Mutation Linked to Neurological Disorders
Mutation could offer insights into Alzheimer’s, Parkinson’s and Huntigton’s Diseases.
Wednesday, October 16, 2013
Scientific News
Liquid Biopsies: Utilization of Circulating Biomarkers for Minimally Invasive Diagnostics Development
Market Trends in Biofluid-based Liquid Biopsies: Deploying Circulating Biomarkers in the Clinic. Enal Razvi, Ph.D., Managing Director, Select Biosciences, Inc.
Watching a Tumour Grow in Real-Time
Researchers from the University of Freiburg have gained new insight into the phases of breast cancer growth.
Childhood Cancer Cells Drain Immune System’s Batteries
Cancer cells in neuroblastoma contain a molecule that breaks down a key energy source for the body’s immune cells, leaving them too physically drained to fight the disease.
Urine Proteins Point to Early-Stage Pancreatic Cancer
A combination of three proteins found at high levels in urine can accurately detect early-stage pancreatic cancer, researchers at the BCI have shown.
Researcher Discovers Trigger of Deadly Melanoma
New research sheds light on the precise trigger that causes melanoma cancer cells to transform from non-invasive cells to invasive killer agents, pinpointing the precise place in the process where "traveling" cancer turns lethal.
Genetic Tug of War
Researchers have reported on a version of genetic parental control in mice that is more targeted, and subtle than canonical imprinting.
Error Correction Mechanism in Cell Division
Cell biologists have reported an advance in understanding the workings of an error correction mechanism that helps cells detect and correct mistakes in cell division early enough to prevent chromosome mis-segregation and aneuploidy, that is, having too many or too few chromosomes.
How to Become a Follicular T Helper Cell
Uncovering the signals that govern the fate of T helper cells is a big step toward improved vaccine design.
Researchers Resurrect Ancient Viruses
Researchers at Massachusetts Eye and Ear and Schepens Eye Research Institute have reconstructed an ancient virus that is highly effective at delivering gene therapies to the liver, muscle, and retina.
Cell Aging Slowed by Putting Brakes on Noisy Transcription
Experiments in yeast hint at ways to extend life of some human cells.
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
2,400+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
3,700+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FREE!