June 1, 2012Cancer Drugs: Better, Cheaper
Cancer drug development is known to be too slow, costly and fraught with failure. Now the U.S. Food and Drug Administration is issuing recommendations for breast cancer trials that would substantially accelerate patient access to new medications while lowering the time and cost of drug development.
The new regulatory guidelines are based in part on groundbreaking, national breast cancer research led by UCSF.
The FDA's new approach is based on a trial design being tested in a clinical study known as I-SPY 2, launched by UCSF in conjunction with a private-public partnership that includes the FDA, the National Institutes of Health, pharmaceutical companies and academic medical centers.
I-SPY 2 combines personalized medicine with a novel investigational design to identify women at high risk of early breast cancer recurrence. It is underway at 19 major cancer research centers around the country.
November 2, 2010
The I-Spy 2 clinical trial is working to shorten the approval process of breast cancer drugs. UCSF breast cancer specialist and I-Spy leader, Dr. Laura Esserman, is featured in this story on NBC Nightly News.
The new I-Spy 2 clinical trial aims to give the "right drug to the right patient at the right time," one doctor said.
October 4, 2010
The Wall Street Journal devoted two pages to an extensive story on Oct. 2 about I-SPY 2, a unique trial designed to accelerate the process of developing new cancer medications. Under the trial’s innovative path toward personalized medicine, scientists for the first time will be able to eliminate at an early point those experimental drugs that show little effectiveness. “Unless we do something different, people are going to give up on doing (cancer) trials,’’ said I-SPY 2 co-leader Laura Esserman, MD, MBA (left), director of the UCSF Carol Franc Buck Breast Care Center. Also showcased was UCSF oncologist Hope S. Rugo, MD (right), director of the UCSF Breast Oncology Clinical Trials Program, and a patient involved in the clinical trial.