Senators Authored 'Breakthrough' Provision in 2012 FDA Reform Law
U.S. Senators Michael Bennet (D-CO), Richard Burr (R-NC), and Orrin Hatch (R-UT) welcomed the U.S. Food and Drug Administration’s (FDA) first approval of a cancer-fighting drug that had been granted a breakthrough therapy designation, thanks to a provision that the Senators successfully included in last year’s FDA Safety and Innovation Act.
The provision allows for expedited FDA approval and provides more flexibility for breakthrough drugs or treatments that show dramatic responses early in development, while still ensuring drug safety and efficacy.
“The first full FDA approval is a milestone for patients fighting this type of leukemia,” Bennet said. “The breakthrough designation is already helping improve the lives of people in Colorado and across the country with a variety of diseases. FDA approval of these drugs will mean that lifesaving treatments will be more readily available for patients.”
“The breakthrough therapies pathway was put in place to expedite the development and review of products targeting promising therapies such as the one FDA approved today,” Burr said. “Today’s approval of the first breakthrough drug is a tremendous achievement on behalf of America’s patients and families battling cancer and other complex diseases. It is my hope that the breakthrough pathway will continue to help FDA and innovators spur on future generations of life-saving treatments for patients and their families nationwide.”
“This first approval of a breakthrough therapies drug is an important step towards getting lifesaving care into the hands of the most at-risk patients as soon as possible,” Hatch said. “Red tape in Washington should not stand in the way of lifesaving care for Utahns or anyone across the country, and my hope is that the FDA will continue to utilize the breakthrough designation to help treat patients with CLL and other diseases.”
The FDA announced Friday it had approved Gazyva (obinutuzumab) to help treat patients with previously untreated chronic lymphocytic leukemia (CLL). CLL is a blood and bone marrow disease that usually gets worse slowly. According to the National Cancer Institute, 15,680 Americans will be diagnosed and 4,580 will die from the disease this year. Gazyva works by helping certain cells in the immune system attack cancer cells.