UNMC study to test ‘breakthrough’ drug in mantle cell lymphoma patients – FDA expected to approve drug in 6 months
The University of Nebraska Medical Center is involved in testing a drug the Food and Drug Administration has fast-tracked towards approval because of its dramatic results in patients with mantle cell lymphoma and other cancers.
“This experimental drug, Ibruitinib, is so promising that the FDA gave it fast track designation which rarely happens,” said Julie M. Vose, M.D., chief of the division of hematology and oncology and Neumann M. and Mildred E. Harris Professor at UNMC. “Patients who’ve been on the treatment have had remarkable results with limited side effects. We are able to offer this to patients through an expanded access program which occurs about six months before the FDA approves it.”
The new study is targeted for patients age 18 and older with mantle cell lymphoma who’ve relapsed – meaning other treatments have failed. The study, which aims to enroll as many patients as possible, is being conducted in about 50 locations across the United States and in Puerto Rico. Those eligible for the study will be provided the drug at no cost.
The FDA designated Ibruitinib as a breakthrough therapy. The designation is intended to expedite the development and review of drugs for serious or life-threatening conditions that demonstrate the drug may have substantial improvement over available therapy. The study will remain open until the medication is FDA approved, which should be by the end of the year, Dr. Vose said.
Dr. Vose, who is principal investigator of the UNMC study, said Ibruitinib works differently than other drugs for this type of cancer. The drug, developed by Pharmacyclics, Inc and Johnson & Johnson’s Janssen Pharmaceutical division, basically poisons one of the pathways that helps the cancer grow.
“It kills the lymphoma,” she said. “It has fairly limited side effects. It’s a pill rather than an intravenous delivery, and it also has potential to be used with other treatments due to the limited side effects.”
Steven “Robert” Whisnant of Morganton, N.C., and his wife, Quteen, came from North Carolina for the trial after his physicians told him there was nothing else they could do. Whisnant has had a dramatic response to the medication as have many other patients, Dr. Vose said.
“I’m thankful that there’s somebody out there trying to find different things to help people because if I hadn’t have gotten the medication, I’d have died,” Whisnant said. “So far it seems to be working. All the tumors in my neck are gone and the ones in my stomach have shrunken. It gives us hope and I’m thankful for that.”
Mantle cell lymphoma is a rare, B-cell non-Hodgkin lymphoma that most often affects men over the age of 60. The disease may be fast or slow growing. It comprises about five percent of all non-Hodgkin lymphomas.
Dr. Vose said results thus far have seen a 75 percent response rate in patients with mantle cell lymphoma whose disease has failed all other treatments.
“We have been involved in several of the first clinical trials with this particular medication,” Dr. Vose said. “We don’t think it’s a cure but it’s been found to be able to keep patients in remission longer to control their symptoms and allow them to have a good quality of life. These patients have very limited other options. This is a breakthrough and works very quickly.”
Clinical trials began on Ibruitinib a few years ago. It also is being tested at other sites for other types of lymphoma, leukemia and multiple myeloma.
Other co-investigators in the study are UNMC physicians Jim Armitage, M.D., Phil Bierman, M.D., and Greg Bociek, M.D.
For more information about the study “An Open Label Treatment Use Protocol for Ibrutinib in Subjects With Relapsed or Refractory Mantle Cell Lymphoma”, contact Maribeth at 402 559-9053 or [email protected] For a complete list of other study locations go to clinicaltrials.gov and search “NCT01833039.”
University of Nebraska Medical Center