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- Posted Wednesday February 1, 2012
FDA approves new skin cancer drug first tested in Arizona by Scottsdale Healthcare and TGen
World's first patient on drug was at the Virginia G. Piper
Cancer Center at Scottsdale Healthcare
SCOTTSDALE, Ariz. - Feb 1, 2012 - A new skin cancer drug tested for
the first time in the world five years ago at the Virginia G. Piper
Cancer Center at Scottsdale Healthcare just received expedited
approval by the U.S. Food and Drug Administration, a remarkable
accomplishment in new drug development.
Vismodegib (GDC-0449) was administered for the first time in the
world Jan. 23, 2007, in a phase I clinical trial at Virginia G.
Piper Cancer Center Clinical Trials at Scottsdale Healthcare, a
partnership with the Translational Genomics Research Institute
(TGen). Vismodegib received FDA approval on Jan. 30, 2012. Clinical
trials progress through three phases and can take up to 10 years or
more to successfully complete.
The drug is the first to receive FDA approval to treat inoperable
basal cell carcinoma. Successful early trial results led to a
broader subsequent study sponsored by Genentech. Continued positive
study results led to Monday's FDA approval for marketing the drug
under the name Erivedge.
Vismodegib is used to treat adult patients with advanced basal cell
carcinoma, the most common type of skin cancer. It is intended for
use in patients with locally advanced basal cell cancer who are not
candidates for surgery or radiation and for patients whose cancer
has spread to other parts of the body (metastatic), according to
the FDA.
Arizona has one of the highest incidences of skin cancer in the
world, and in the United States two million new cases of basal cell
carcinoma are diagnosed every year. Most instances of basal cell
cancer can be effectively treated, but in some cases, the cancer
cells spread and develop an aggressive form of the cancer that does
not respond to standard surgical treatment.
"Until now, we did not have any treatments that can effectively
slow the tumor growth in these patients with advanced skin cancer,"
said Daniel Von Hoff, MD, lead investigator. Dr. Von Hoff is
physician-in-chief at TGen and chief scientific officer at the
Virginia G. Piper Cancer Center Clinical Trials at Scottsdale
Healthcare, where cancer patients receive treatment with promising
new drugs.
"The drug works by inhibiting the Hedgehog pathway that is active
in most basal cell cancers, preventing development, growth and
survival of certain cancer cells. Results showed a durable clinical
benefit - tumor shrinkage visible on X-ray or other physical exam
or improvement in symptoms without tumor growth," said Glen Weiss,
MD, director of Thoracic Oncology at Virginia G. Piper Cancer
Center Clinical Trials and Clinical Associate Professor and
Translational Physician Scientist at TGen.
Patient response during the clinical trials was assessed through
physical examination and imaging. "Integrating genomic data with
state-of-the-art clinical and imaging information to develop and
apply targeted therapies has certainly taken a major step forward
with the encouraging results from the Hedgehog trial," added Ron
Korn, MD, a radiologist and medical director of the Virginia G.
Piper Cancer Center at Scottsdale Healthcare.
San Francisco-based Genentech developed Vismodegib. Successful
results of early clinical trials at the Virginia G. Piper Cancer
Center at Scottsdale Healthcare, Johns Hopkins University and
Karmanos Cancer Institute were published in the Sept. 17, 2009 New
England Journal of Medicine and led to interest in increased access
to the drug.
"In some patients there is progression to life-threatening, locally
advanced or metastatic tumors. Approved as a pill to be taken once
a day, we believe this new drug represents an opportunity to
improve quality of life for these patients," said Dr. Weiss.
Individuals seeking information about eligibility to participate in
clinical trials at the Virginia G. Piper Cancer Center at
Scottsdale Healthcare may contact the cancer care coordinator at
480-323-1339; toll free at 1-877-273-3713 or via email at
[email protected]
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About the Virginia G. Piper Cancer Center at Scottsdale
Healthcare
The Virginia G. Piper Cancer Center at Scottsdale Healthcare in
Scottsdale, Ariz. offers comprehensive cancer treatment and
research through Phase I clinical trials, diagnosis, prevention and
support services in collaboration with leading scientific
researchers and community oncologists. Scottsdale Healthcare is the
nonprofit parent organization of the Virginia G. Piper Cancer
Center at Scottsdale Healthcare, Scottsdale Healthcare Research
Institute, Scottsdale Healthcare Osborn Medical Center, Scottsdale
Healthcare Shea Medical Center and Scottsdale Healthcare Thompson
Peak Hospital. For more information, visit www.shc.org.
Press Contact:
Keith Jones
Public Relations Director, Virginia G. Piper Cancer Center
480-323-1383
[email protected]
