Tasigna Approval Widened to Include Early Stages of Rare
Leukemia
06/18/10
FRIDAY, June 18 (HealthDay News) -- The anti-cancer drug Tasigna
(nilotinib) has received new approval from the U.S. Food and Drug
Administration to include people in the early stages of a rare
blood cancer called Philadelphia chromosome positive chronic phase
chronic myeloid leukemia (Ph+CP-CML), the agency said in a news
release.
The disease, linked to a genetic abnormality, progresses slowly
and affects the blood and bone marrow. Tasigna is thought to block
a signal that causes leukemic cells to develop. The drug was
approved in October 2007 for people in the disease's later
stages.
Users of Tasigna, however, are at greater risk of an abnormal
heart rhythm disorder called QT prolongation. The FDA said earlier
this year it sanctioned an updated medication guide and other
strategies to inform patients and doctors of the drug's risks.
The most common side effects reported during clinical testing
include: itching, headache, nausea, fatigue and muscle pain.
Serious adverse reactions affecting the blood could include a
decrease in bone marrow activity, low blood platelets, anemia and a
decrease in infection-fighting white blood cells, the agency
said.
Tasigna is marketed by Novartis Pharmaceuticals, based in East
Hanover, N.J.
More information
To learn more about this drug's approval history, visit the
FDA.
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