FDA News Release
FDA expands approved use of Imbruvica for chronic lymphocytic
leukemia
New clinical data supports traditional approval for CLL
For Immediate Release
July 28, 2014
Release
The U.S. Food and Drug Administration today expanded the
approved use of Imbruvica (ibrutinib) to treat patients with
chronic lymphocytic leukemia (CLL) who carry a deletion in
chromosome 17 (17p deletion), which is associated with poor
responses to standard treatment for CLL. Imbruvica received a
breakthrough therapy designation for this use.
The FDA is also approving new labeling to reflect that
Imbruvica's clinical benefit in treating CLL has been verified. In
February 2014, Imbruvica received accelerated approval to treat CLL
based on its effect on overall response rate. New clinical trial
results examining progression-free survival and overall survival
have confirmed the drug's clinical benefit.
A type of non-Hodgkin lymphoma, CLL is a rare blood and bone
marrow disease that usually gets worse slowly over time, causing a
gradual increase in white blood cells called B lymphocytes, or B
cells. The National Cancer Institute estimates that 15,720
Americans will be diagnosed and 4,600 will die from CLL in 2014.
Imbruvica works by blocking the enzyme that allows cancer cells to
grow and divide.
"We continue to see advances in the availability of therapies to
treat chronic lymphocytic leukemia, especially for
difficult-to-treat patient populations," said Richard Pazdur, M.D.,
director of the Office of Hematology and Oncology Products in the
FDA's Center for Drug Evaluation and Research. "Imbruvica is the
fourth drug approved to treat CLL that received a breakthrough
therapy designation, reflecting the promise of the breakthrough
therapy designation program and demonstrating the FDA's commitment
to working cooperatively with companies to expedite the
development, review and approval of these important new drugs."
The other three drugs approved to treat CLL that received
breakthrough designations are Gazyva (obinutuzumab) in November
2013, Arzerra (ofatumumab) in April 2014 and Zydelig (idelalisib)
in July 2014. Imbruvica's application for accelerated approval to
treat CLL did not receive breakthrough therapy designation.
Today's approval actions for Imbruvica are based on a clinical
study of 391 previously treated participants, 127 of whom had CLL
with 17p deletion. Participants were randomly assigned to receive
Imbruvica or Arzerra until disease progression or side effects
became intolerable.
The trial was stopped early for efficacy after a pre-planned
interim analysis showed Imbruvica-treated participants experienced
a 78 percent reduction in risk of disease progression or death
(progression-free survival). Results also showed a 57 percent
reduction in risk of death (overall survival) in participants
treated with Imbruvica. Of the 127 participants who had CLL with
17p deletion, those treated with Imbruvica experienced a 75 percent
reduction in risk of disease progression or death.
The most common side effects associated with Imbruvica observed
in the clinical study include low levels of platelets in the blood
(thrombocytopenia), a decrease in infection-fighting white blood
cells called neutrophils (neutropenia), diarrhea, low red blood
cells (anemia), fatigue, pain in the muscles and bones
(musculoskeletal pain), upper respiratory tract infection, rash,
nausea and fever (pyrexia).
Imbruvica's new use is being approved more than two months ahead
of the product's prescription drug user fee goal date of Oct. 7,
2014, the date the FDA was scheduled to complete review of the drug
application. The FDA reviewed Imbruvica's application for this new
use under the agency's priority review program, which provides for
an expedited review of drugs that are intended to treat a serious
disease or condition and, if approved, would offer significant
improvement compared to marketed products.
Imbruvica also received accelerated approval in November 2013
for the treatment of patients with mantle cell lymphoma who have
received at least one prior therapy. Clinical studies to verify and
describe Imbruvica's clinical benefit in mantle cell lymphoma are
ongoing.
Imbruvica is co-marketed by Pharmacyclics, based in Sunnyvale,
Calif., and Janssen Biotech, based in Horsham, Penn.
The FDA, an agency within the U.S. Department of Health and
Human Services, protects the public health by assuring the safety,
effectiveness, and security of human and veterinary drugs, vaccines
and other biological products for human use, and medical devices.
The agency also is responsible for the safety and security of our
nation's food supply, cosmetics, dietary supplements, products that
give off electronic radiation, and for regulating tobacco
products.
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