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ARIAD Pharmaceuticals, Inc.
today announced that following a
priority review, the U.S. Food and Drug Administration (FDA) has granted
accelerated approval of Iclusig™ (ponatinib) for the treatment of adult
patients with chronic, accelerated or blast phase chronic myeloid leukemia
(CML) that is resistant or intolerant to prior tyrosine kinase inhibitor (TKI)
therapy or Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+
ALL) that is resistant or intolerant to prior TKI therapy.
“Today's FDA approval of Iclusig is an important advance in the treatment of
patients with CML and Ph+ ALL who are resistant or intolerant to prior TKI
therapy,” stated Harvey J. Berger, M.D., chairman and chief executive officer
of ARIAD. “Within less than five years, we were able to bring Iclusig from the
start of clinical development to U.S. approval, achieving a major milestone in
ARIAD's history. We have now transformed ARIAD into a commercial oncology
company addressing major unmet medical needs for cancer patients.”
Approximately 5,000 new cases of CML are diagnosed each year in the U.S. CML
patients treated with TKIs can develop resistance or intolerance over time to
these therapies. Iclusig is a targeted cancer medicine discovered and
developed at ARIAD. It was designed by ARIAD scientists using ARIAD's platform
of computational chemistry and structure-based drug design to inhibit BCR-ABL,
including drug-resistant mutants that arise during treatment. Iclusig is the
only TKI that demonstrates activity against the T315I gatekeeper mutation of
BCR-ABL, the most common mutation occurring in approximately ten percent of
patients with drug resistance.
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