On March 24, 2015 ARIAD Pharmaceuticals and Medison Pharma reported that the Israeli Ministry of Health has granted regulatory approval for Iclusig (ponatinib) in Israel for adult patients with (Press release, Ariad, MAR 24, 2015, View Source [SID:1234502503]): Schedule your 30 min Free 1stOncology Demo! Chronic phase, accelerated phase, or blast phase chronic myeloid leukaemia (CML) who are resistant to dasatinib or nilotinib, who are intolerant to dasatinib or nilotinib and for whom subsequent treatment with imatinib is not clinically appropriate, or who have the T315I mutation
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Philadelphia chromosome-positive acute lymphoblastic leukaemia (Ph+ ALL) who are resistant to dasatinib, who are intolerant to dasatinib and for whom subsequent treatment with imatinib is not clinically appropriate, or who have the T315I mutation.
ARIAD submitted its application for Iclusig to the Israeli Ministry of Health in June 2014. Commercial launch of Iclusig is expected to occur in the second quarter of 2015.
"Iclusig is an important addition to the treatment armamentarium," said Professor Arnon Nagler, head of hematology and the Bone Marrow Transplant Division at the Chaim Sheba Medical Center in Israel, and chairman of the Israeli Bone Marrow Transplant Association. Dr. Nagler added, "Patients in Israel have an excellent health care system, and having this potent and promising drug is an important addition to the national health basket."
"The swift approval by the Ministry of Health in Israel speaks to the importance of this new therapy to appropriate patients in Israel. We look forward to continued success working with ARIAD and fulfilling Medison’s vision to provide innovative and unique treatments to patients in Israel," said Meir Jakobsohn, chief executive officer and founder of Medison Pharma.
"We are very pleased with the rapid approval of Iclusig in Israel and the strength of our ongoing collaboration with Medison. This milestone further recognizes the major importance of Iclusig for the treatment of patients with refractory Philadelphia-positive leukemias," stated Harvey J. Berger, M.D., chairman and chief executive officer of ARIAD. "Approval in Israel is an important step in our effort to make Iclusig available to CML patients in need in key regions throughout the world."
The Ministry of Health decision was based on results from the pivotal Phase 2 PACE (Ponatinib Ph+ ALL and CML Evaluation) trial in patients with CML or Ph+ ALL who were resistant or intolerant to prior tyrosine kinase inhibitor (TKI) therapy, or who had the T315I mutation of BCR-ABL. Iclusig demonstrated anti-leukemic activity achieving a major cytogenetic response (MCyR) in 54 percent of chronic-phase CML patients and in 70 percent of patients with the T315I mutation.1, 2 MCyR within the first 12 months was the primary endpoint of the PACE trial for chronic-phase patients.1, 2
In patients with advanced disease, 57 percent of accelerated-phase CML patients and 34 percent of blast-phase CML patients achieved a major hematologic response (MaHR) with Iclusig. MaHR within the first 6 months was the primary endpoint in the trial for patients with advanced disease. 1, 2
The most common serious adverse reactions >1% were pancreatitis, pyrexia, abdominal pain, myocardial infarction, atrial fibrillation, anaemia, platelet count decreased, febrile neutropenia, cardiac failure, lipase increased, dyspnea, diarrhoea, neutrophil count decreased, pancytopenia, and pericardial effusion.
Serious arterial cardiovascular, cerebrovascular, and peripheral vascular occlusive adverse reactions occurred in 6.7%, 5.6%, and 5.1% of Iclusig treated patients, respectively. Serious venous occlusive reactions occurred in 4.5% of patients. The most common (≥20%) adverse reactions of any severity were decrease in platelet count, rash, dry skin, and abdominal pain.2
Based on the European Medicines Agency’s orphan drug designation and the HAEMACARE project, it is estimated that there are approximately 700 patients with CML in Israel.