Sen. Bennet’s Report
It’s pretty easy these days to be frustrated with the state of politics in Washington. I often call it the land of flickering lights, lurching from one manufactured crisis to another.
Despite this dysfunction, however, there are glimmers of hope from time to time. One such glimmer comes in the form of the bipartisan Advancing Breakthrough Therapies for Patients Act that recently passed into law. The bill reforms the Food and Drug Administration’s (FDA) drug approval process and creates a new “breakthrough therapy” designation for treatments that show dramatic responses early in development, allowing these medications to be expedited through the approval process and into the hands of patients who need them the most.
Coloradan Larry Rosenberg has been living with chronic lymphocytic Leukemia (CLL) — the most common form of leukemia — for over a decade. The disease, which starts in the white blood cells in bone marrow, builds over time, later invading the blood and causing tumors throughout the body. Larry’s cancer recently became more aggressive and he was forced to undergo two types of chemotherapy — one of which made him so ill within 10 minutes that he was unable to continue with it.
There seemed to be few alternatives. But Larry and his family weren’t about to give up.
Larry’s daughter discovered a groundbreaking clinical trial at the University of Colorado Hospital. The trial, spearheaded by Dr. Daniel Pollyea, pairs a drug called ibrutinib, which received a breakthrough designation from the FDA, with another approved therapy. Pollyea was looking for participants and Larry was a perfect candidate.
Larry became a part of the trial last September. Instead of painful and invasive chemotherapy treatments, Larry now just takes a few pills daily. His tumors have decreased significantly and he maintains a good quality of life. As Larry said to me when I met with him recently, “It’s a miracle drug.”
This story is a refreshing example of Washington actually doing its job. Last year in April, ibrutinib was fast-tracked through the FDA because of the “breakthrough therapy” provision we worked to pass along with Republican senators Richard Burr and Orrin Hatch, as part of 2012’s FDA Safety and Innovation Act.
Once the FDA determines that a drug meets the criteria to be designated a “breakthrough therapy,” it is required to safely accelerate the development and evaluation of the drug, which means establishing an interactive development process, providing timely advice to the developer of the drug, and shortening the duration and number of participants in clinical trials when appropriate. This ensures that lifesaving drugs aren’t mired in red-tape in Washington and are actually getting to the patients who need them.
Which brings us back to Larry. Just a few weeks ago, the FDA approved this drug for widespread use with patients who have CLL, a mere 10 months after it received “breakthrough therapy” status. Compare that to the average FDA approval process, which can take more than a decade.
Since the passage of this provision, more than 40 other drugs have received the “breakthrough therapy” designation, treating everything from cancer to hepatitis C to cystic fibrosis.
As Larry’s doctor, Pollyea, said, “This is a game changer.”
Every new breakthrough drug is a potential victory for patients and their families facing life threatening illnesses. This “game changer” will hopefully allow thousands of Americans a glimmer of hope and a chance at longer, healthier lives.