Tasigna Approval Widened to Include Early Stages of Rare Leukemia

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.