Posted: Monday, March 25, 2013 9:45 pm | Updated: 9:45 pm, Mon Mar 25, 2013.
By LESLIE LAKE
Hour Staff Writer | 0 comments
NORWALK -- While Robert Levine, M.D., was treating patients at his Norwalk neurology practice, he had been battling his own medical issues for the past 19 years. After many courses of chemotherapy to treat his non-Hodgkin lymphoma, Levine is now participating in a clinical trial for a new cancer drug therapy and has seen the progression of the disease arrested and his symptoms disappear.
The medication, Ibrutinib, was recently granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration -- and Norwalk Hospital is the only Connecticut hospital to be participating in clinical trials for the promising new cancer therapy.
"This is being used in settings where patients have run out of options," said Richard Frank, M.D., medical oncologist and director of cancer research at Norwalk Hospital. "While this is not a cure, the drugs are restoring improvement in functional activity."
Ibrutinib has shown remarkable results in clinical trials to treat a variety of non-Hodgkin lymphomas as well as chronic lymphocytic leukemia (CLL). It is not yet available for general use but is available in ongoing research studies. The breakthrough status applies to the treatment of relapsed or refractory mantle cell lymphoma (MCL) and Waldenstrom's macroglobulinemia.
According to Frank, there more than 60,000 new cases of CLL and less than 7,000 new cases of MCL each year.
"The designation was created to speed up the development and review of treatments that may demonstrate substantial improvement over existing therapies," said Frank. "The Breakthrough Therapy Designation represents an important step towards accelerating drug development timelines and ultimately making this important medicine available to all the patients who need it."
Ibutrinib targets the signaling enzyme BTK that causes cancer cells to replicate. "Ibrutinib is a first-in-class oral therapy that is a selective, irreversible inhibitor of Bruton's tyrosine kinase (BTK), a critical signaling kinase in the B-cell receptor pathway for tumor cell survival and proliferation. Ibrutinib is being developed as a treatment for various B-cell malignancies," according the the Ibrutinib manufacturer Pharmacyclics' website.
"I've had non-Hodgkin lymphoma, which is the same as chronic lymphocytic leukemia," said Levine, who had undergone numerous courses of chemotherapy to keep the disease in check.
When the disease began to advance, Levine was sent to various centers, including Yale, Harvard and Sloan-Kettering Memorial Hospital.
"I was told at Sloan that I needed a bone marrow transplant, but that it couldn't be done until the disease was arrested," Levine said. "At Sloan I was told about a phase I study at Weill Cornell of a new medication, Ibrutinib. I started it with the idea to stop the progression of the disease and within a couple of weeks, the disease was completely arrested. I never got the transplant, and I've been symptom-free."
Levine, who retired from his practice last year, takes six pills a day with no side effects.
"I think within a short period of time, people with various malignancies will not have to go through cancer therapy," Levine said. "I see this as the future of cancer care."
For information on the SPARK study and other cancer research trials at Norwalk Hospital, contact Jennifer Long, APRN at (203) 852-2996.
Sentiment: Strong Buy
No revelations, other than this is the first time I have seen any results on the FDA site for Ibrutinib. Interesting information shown, but again, no revelations. Put it on your periodic Ibrutinib searches
Looking forward to the next few months.
Sentiment: Strong Buy
Department of Health and Human Services Food and Drug Administration Creating an Alternative Approval Pathway for Certain Drugs Intended to Address Unmet Medical Need Part 15 Public Hearing February 4, 2013 Dr. John Byrd is leading a research team at The Ohio State University where they havereported positive clinical trial results for patients with relapsed I refractory CLL. Patients treatedwith ibrutinib in combination with the monoclonal antibody drug Rituximab. Ibrutinib could be approved under an alternative pathway for advanced stage CLL patients while clinical trialscontinue for treatment-naive CLL patients.Is this what you were talking about?
Sentiment: Strong Buy