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FDA grants full approval to Iclusig for CML, Ph+ALL
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The FDA granted full approval to ponatinib for the treatment of adults with chronic phase, accelerated phase or blast phase chronic myeloid leukemia or Philadelphia chromosome–positive acute lymphoblastic leukemia, according to the drug’s manufacturer.
The indication included patients for whom no other tyrosine kinase inhibitor therapy is indicated, and for those with T315I–positive CML or T315I–positive Philadelphia chromosome–positive ALL (Ph+ ALL).
The full approval and label update of ponatinib (Iclusig, Ariad) was based on 48 months of follow-up data from the pivotal phase 2 PACE clinical trial, which included 449 heavily pretreated patients with resistant or intolerant CML or Ph+ALL.
Results showed 55% of patients achieved major cytogenetic response and 39% achieved a major molecular response with ponatinib.
“The data on ponatinib continue to show that with a minimum follow-up of 48 months, many chronic phase CML patients in the PACE trial have retained long-term cytogenetic and molecular responses,” Timothy P. Clackson, PhD, president of research and development and chief scientific officer at Ariad, said in a press release.
Over the 4-year follow-up, patients experienced arterial occlusive (33%), cardiac vascular (21%), peripheral vascular (12%) cerebrovascular arterial occlusive (9%) and venous thromboembolic (6%) events.
The most common adverse events included hypertension (69%), rash (63%), abdominal pain (48%), fatigue (47%), headache (43%), arterial ischemia (42%), dry skin (42%), constipation (41%), arthralgia (32%), nausea (28%), pyrexia (26%), peripheral neuropathy (24%), myalgia (24%), pain in extremity (23%), back pain (21%) and diarrhea (20%).
“With this label update we are also now able to communicate to physicians that patients have experienced deep responses on ponatinib, measured by major molecular response,” Clackson added. “We are continuing our efforts to understand the optimal ponatinib dose for patients with the OPTIC (Optimizing Ponatinib Treatment In CML) post-marketing study.”