Navigation Links
FDA approves new skin cancer drug first tested in Arizona by Scottsdale Healthcare and TGen
Date:2/1/2012

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.


'/>"/>
Contact: Steve Yozwiak
syozwiak@tgen.org
602-343-8704
The Translational Genomics Research Institute
Source:Eurekalert

Related medicine news :

1. FDA Approves First Combo Drug for Diabetes, Cholesterol
2. FDA Approves Novel Melanoma Drug
3. FDA Approves Blood Thinner Brilinta for Heart Patients
4. FDA Approves Test That Spots Aggressive Breast Cancer
5. FDA Approves Test That Spots HER2-Positive Breast Cancers
6. FDA Approves Another New Drug to Fight Hepatitis C
7. FDA approves new drug for advanced melanoma
8. FDA approves ipilimumab, an immunotherapy, to treat metastatic melanoma
9. FDA Approves 1st New Lupus Drug in More Than 50 Years
10. FDA Approves First 3D Mammogram Device
11. FDA Approves First Pacemaker Deemed Safe During MRIs
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/26/2016)... ... 26, 2016 , ... Brent Kasmer, a legally blind and certified personal trainer is helping to ... app. The fitness app plans to fix the two major problems leading the fitness industry ... fits all type program , They don’t eliminate all the reasons people quit ...
(Date:6/25/2016)... Viejo, California (PRWEB) , ... June 25, 2016 , ... ... to fit their specific project," said Christina Austin - CEO of Pixel Film Studios. ... fully customizable and all within Final Cut Pro X . Simply select a ...
(Date:6/25/2016)... (PRWEB) , ... June 25, 2016 , ... Conventional wisdom ... of success. In terms of the latter, setting the bar too high can result ... more than just slow progress toward their goal. , Research from PsychTests.com ...
(Date:6/24/2016)... ... 24, 2016 , ... The Pulmonary Hypertension Association (PHA) learned ... receive two significant new grants to support its work to advance research and ... by recognizing patients, medical professionals and scientists for their work in fighting pulmonary ...
(Date:6/24/2016)... ... June 24, 2016 , ... People across the U.S. are sharpening their pencils ... an essay contest in which patients and their families pay tribute to a genetic ... 2016 National Society of Genetic Counselors (NSGC) Annual Education Conference (AEC) this September. ...
Breaking Medicine News(10 mins):
(Date:6/24/2016)... , June 24, 2016  Consumers have ... and regulators/payers have placed more emphasis on patient ... patient support programs in the pharmaceutical industry have ... medications. Consequently, pharmaceutical companies are focusing on becoming ... are providing products and services that improve health. ...
(Date:6/24/2016)... , June 24, 2016  Global Blood Therapeutics, ... company developing novel therapeutics for the treatment of ... announced the closing of its previously announced underwritten ... at the public offering price of $18.75 per ... were offered by GBT. GBT estimates net proceeds ...
(Date:6/24/2016)... 2016 Dublin ... addition of the " Global Markets for Spectroscopy ... This report focuses on the ... review, including its applications in various applications. The report ... includes three main industries: pharmaceutical and biotechnology, food and ...
Breaking Medicine Technology: