Iclusig is a drug used in the treatment of Philadelphia chromosome positive acute
lymphoblastic leukemia or chronic myeloid leukemia which have not responded to other
similar drugs or has become resistant to those drugs. Iclusig is categorized as
a tyrosine-kinase inhibitor; it disrupts enzymes within cancer cells and is generally
prescribed for patients with cancers which are particularly hard to treat or have
become resistant to other similar drugs. Kinase inhibitors work by halting the growth
and spread of cancer cells, and presently there are only a handful of drugs in this
class approved in the treatment of these two blood cancers.
Iclusig’s price tag is startling—about $115,000 per year per patient
however chronic myeloid leukemia is relatively rare, with about 5,000 new diagnoses
per year in the United States. Six hundred deaths from chronic myeloid leukemia
occur each year, making the need for a drug which stops the progress of blood cancers
all the more important. Gleevec is the drug most often used in the treatment of
CML, however in 20-30% of all cases, the patient’s cancer cells become resistant
to the drug.
Why Have Sales and Marketing of Iclusig Been Suspended?
Ariad Pharmaceuticals suspended sales of Iclusig in a joint decision with the FDA
after more than a dozen patients enrolled in clinical trials died from serious blood
clots and others became seriously ill. An FDA spokeswoman stated that preliminary
data indicated that possibly 14 deaths were directly linked to Iclusig in a pair
of clinical trials with approximately 530 participants. Ariad has been asked by
the FDA to provide detailed information regarding any deaths which occurred during
Iclusig clinical trials.
Among those with a median treatment duration of 1.3 years, 24% experienced fatal
or life-threatening cardiovascular events; among those with a median treatment duration
of 2.7 years, 48% of Iclusig patients suffered severe narrowing of the blood vessels,
loss of blood flow to extremities, strokes, and fatal or life-threatening heart
attacks. While these numbers appear to point to the fact that the length of treatment
correlates to the severity of adverse symptoms, some patients developed serious
side effects as soon as two weeks following beginning Iclusig.
What is the FDA’s Stance on Iclusig?
Although Iclusig gained FDA approval, a boxed label warning regarding the risks
of blood clots and liver toxicity accompanied that approval. Unfortunately, it appears
there is a much greater risk of blood clots than previously believed. The FDA recently
alerted healthcare professionals of the potential risks in those being treated with
Iclusig after higher-than-expected rates of arterial thrombosis were observed in
a newly analyzed trial. Enrollment in ongoing or new Iclusig trials has been stopped,
at least temporarily. The FDA approved Iclusig last December, almost three months
ahead of schedule under a special program which approves drugs which can potentially
provide effective therapy when no alternatives exist.
The program allows access to promising new drugs for those whose health condition
may preclude them from waiting significant lengths of time for a new drug to be
approved. At the time the FDA granted Ariad Pharmaceuticals approval for Iclusig,
they also asked that Ariad continue to conduct additional therapies to confirm the
clinical benefits and safety of the drug. The FDA issued a Drug Safety Communications
recently which stated the agency was investigating the increasing frequency of serious,
life-threatening blood clots and narrowing of blood vessels among those taking Iclusig.
The FDA concluded that clinicians should assess the risk versus benefits of Iclusig
on a case-by-case basis. Ariad Pharmaceuticals representatives stress that the suspension
is temporary and that those patients who are doing well on Iclusig can remain on
the drug after completing a special application.
What are the Dangers/Risks Associated With Iclusig?
Clinical trials conducted prior to Iclusig’s FDA approval showed that serious
arterial blood clots occurred in approximately 8% of those patients taking the drug,
while blood clots in the veins occurred in approximately 3% of patients taking Iclusig.
More recent data shows that 20% or more of Iclusig patients have suffered narrowing
of the blood vessels or blood clots. One particular clinical trial concluded that
24% of those taking the drug experienced a serious cardiovascular event such as
a stroke, heart attack or blood clot. Yet another trial showed that a staggering
48% of Iclusig patients suffered a serious cardiovascular event.
What Side Effects are Associated with Iclusig?
Serious side effects associated with Iclusig include pressure in the chest, pain
in the jaw, neck, back or arms, shortness of breath, chest pain, narrowing of arteries
in the arms and legs, coronary artery disease which worsens significantly, narrowing
of the large arteries to the brain, congestive heart failure, blood clots in the
eye, decreased vision, liver toxicity, pancreatitis, gastrointestinal perforation
and hypertensive crisis. Less serious side effects include fluid retention, compromised
wound healing, abdominal pain, chronic headache, anemia, fatigue, constipation,
dizziness and dry skin.
Do I Have an Iclusig Claim?
Those patients who have suffered harm after taking Iclusig could be eligible for
an Iclusig lawsuit. Although the original packaging did list some potentially serious
health risks, the percentage of those expected to experience those serious or fatal
events was listed as much lower than the actual numbers. Patients with CML certainly
don’t expect to suffer additional, serious health issues or to be at risk
for death from a cardiovascular event due to taking Iclusig. It can be beneficial
for those who have taken Iclusig to discuss their potential claim with a knowledgeable
Iclusig attorney who can discuss potential options.
How Can an Iclusig Attorney Help Me?
An experienced Iclusig attorney can help those who have suffered serious, adverse
health events after taking Iclusig. There are a number of factors which must be
considered, including the dosage of Iclusig, the length of time the drug was taken
and the level of harm sustained from taking the drug. Your Iclusig attorney will
consider the statute of limitations, when making an assessment of your case and
will base that assessment on the specific facts surrounding your case.
Who Was Given Iclusig?
Patients who enrolled in Iclusig trials were given the drug; in one of those trials
449 patients were enrolled however there was no control group; all patients in this
particular trial were treated with Iclusig. Some believe this lack of a control
group was a mistake, however because most of those with CML are extremely ill, the
decision was made to treat all participants in the trial with the Iclusig. In this
particular Iclusig clinical trial, over half of all patients with CML achieved major
cytogenic response after taking Iclusig for approximately nine and a half months.
Unfortunately, a significant number of those enrolled in Iclusig clinical trials
have suffered serious, adverse health issues.
Where Were/Are the Iclusig Clinical Trials Being Conducted?
There were a number of Iclusig clinical trials conducted, including the PACE and
the ERIC trials. Results from the PACE trial were the primary basis for Iclusig’s
accelerated approval. Other sites include: Los Angeles at the UCLA Ronald Regan
Medical Center; Tampa, FL at the H. Lee Moffitt Cancer Center; Two Iclusig clinical
trials in MI, at the University of Michigan Medical Center and the Karmanos Cancer
Institute; a Boston, MA clinical trial at the Dana-Farber Cancer Institute; Two
IL Iclusig clinical trials at The University of Chicago and the Northwestern University
Feinberg School of Medicine; an Atlanta, GA trial at the Emory Winship Cancer Institute;
a Baltimore, MD trial at the University of Maryland; a Lincoln, NE trial at Nebraska
Hematology-Oncology; Three New York clinical trials, at the Roswell Park Cancer
Institute, the Weill Medical College of Cornell University and Memorial Sloan-Kettering
Cancer Center; a clinical trial at the University of Maryland in Baltimore, MD;
a St. Louis, MO trial at the Washington University School of Medicine; a clinical
trial at the MD Anderson Cancer Center in Houston, TX; a trial in Philadelphia,
PA, at the Jeanes Hospital of Temple University Health System; a Portland, Oregon
rial at the Oregon Health and Sciences University; a Durham, NC trial at Duke University
Medical Center; a Hackensack, NJ trial at Northern New Jersey Cancer Associates;
A Salt Lake City, UT trial at the Huntsman Cancer Institute and a clinical trial
at the Fred Hutchinson Cancer Research Center in Seattle, WA.