Iclusig Available Again After FDA Investigation

ICLUSIG (ponatinib) tablets
ICLUSIG (ponatinib) tablets

ARIAD announced that Iclusig (ponatinib) is available again for adults with refractory chronic myeloid leukemia and Philadelphia-chromosome positive acute lymphoblastic leukemia in the U.S.

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In October 2013, the FDA had suspended the marketing and sales of Iclusig due to the risk of life-threatening blood clots and severe narrowing of blood vessels. Then in December 2013, the FDA approved  revised prescribing information and a communications Risk Evaluation and Mitigation Strategy (REMS) that allowed Iclusig's marketing and distribution to resume.

Iclusig is now indicated for the treatment of adult patients with:

  • T315I-positive chronic myeloid leukemia (chronic phase, accelerated phase, or blast phase) or T315I-positive Philadelphia chromosome positive (Ph+) acute lymphoblastic leukemia, or
  • Chronic phase, accelerated phase, or blast phase chronic myeloid leukemia or Ph+ acute lymphoblastic leukemia for whom no other tyrosine-kinase inhibitor therapy is indicated

ARIAD expects most patients to transition from the IND program to commercial therapy by the end of the first quarter of 2014. The Iclusig IND program is now closed to new patients with Philadelphia-positive leukemias.

Biologics, Inc., ARIAD's specialty pharmacy, is in the process of filling prescriptions and distributing Iclusig to patients.

For more information call (855) 447-7277 or visit Iclusig.com.