ICLUSIG (ponatinib) tablets is a prescription medicine. ICLUSIG (ponatinib) tablets is used to treat chronic myeloid leukemia (CML).
INDICATIONS AND USAGE
Iclusig is a kinase inhibitor indicated for the treatment of adult patients with chronic phase, accelerated phase, or blast phase chronic myeloid leukemia (CML) that is resistant or intolerant to prior tyrosine kinase inhibitor therapy or Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ALL) that
is resistant or intolerant to prior tyrosine kinase inhibitor therapy.
This indication is based upon response rate. There are no trials verifying an improvement in disease-related symptoms or increased survival with Iclusig.
DOSAGE FORMS & STRENGTHS: Tablets: 15 mg and 45 mg
Manufactured By: ARIAD Pharmaceuticals, Inc.
Prescribing Information URL: Click Here
South Delhi Pharma facilitate the supply of “ICLUSIG (ponatinib) FDA Approved” medication. Supplied under Named Patient Program to all locations in India and other part of countries. Anti-Cancer drugs is available upon request after fulfilling the legal requirement (if applicable). To get best price share your mobile number and email ID.
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Ponatinib was approved by the US FDA on December 14, 2012, for patients with resistant or intolerant CML and Ph+ ALL, based on results of the PACE phase II trial reported days earlier at the annual ASH meeting. Because the approval was under the FDA Accelerated Approval program the applicant was required to carry out additional studies. Based on these additional studies, the FDA granted in 2016 full approval and updated the label to include patients with chronic phase, accelerated phase, or blast phase chronic myeloid leukemia and Philadelphia chromosome-positive acute lymphoblastic leukemia for whom no other tyrosine kinase inhibitor therapy is indicated. Approval was also granted for T315I-positive and T315I-positive Philadelphia chromosome positive acute lymphoblastic leukemia.