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Ponatinib, sold under the brand name Iclusig, is a medication used for the treatment of chronic myeloid leukemia and Philadelphia chromosome–positive (Ph+) acute lymphoblastic leukemia. It was developed by Ariad Pharmaceuticals. It is a multi-targeted tyrosine-kinase inhibitor. Some forms of chronic myeloid leukemia, those that have the T315I mutation, are resistant to current therapies such as imatinib. Ponatinib has been designed to be effective against these types of tumors.
Read the full article on WikipediaChronic Myeloid Leukaemia (CML) Clinical criteria: Treatment Phase: Initial treatment The treatment must be the sole PBS-subsidised therapy for this condition, AND Patient must have failed an adequate trial of dasatinib confirmed through a pathology report from an Approved Pathology Authority; OR Patient must have developed intolerance to dasatinib of a severity necessitating permanent treatment withdrawal, AND Patient must have failed an adequate trial of nilotinib confirmed through a pathology report from an Approved Pathology Authority; OR Patient must have developed intolerance to nilotinib of a severity necessitating permanent treatment withdrawal; OR Patient must not be eligible for PBS-subsidised treatment with nilotinib because the patient has a blast crisis. Treatment criteria: Must be treated by a medical practitioner. Failure of an adequate trial of dasatinib or nilotinib is defined as: 1. Lack of response to dasatinib or nilotinib therapy, defined as either: (i) failure to achieve a haematological response after a minimum of 3 months therapy with dasatinib or nilotinib; or (ii) failure to achieve any cytogenetic response after a minimum of 6 months therapy with dasatinib or nilotinib as demonstrated on bone marrow biopsy by presence of greater than 95% Philadelphia chromosome positive cells; or (iii) failure to achieve a major cytogenetic response or a peripheral blood BCR-ABL level of less than 1% after a minimum of 12 months therapy with dasatinib or nilotinib; OR 2. Loss of a previously documented major cytogenetic response (demonstrated by the presence of greater than 35% Ph positive cells on bone marrow biopsy), during ongoing dasatinib or nilotinib therapy; OR 3. Loss of a previously demonstrated molecular response (demonstrated by peripheral blood BCR-ABL levels increasing consecutively in value by at least 5 fold to a level of greater than 0.1% confirmed on a subsequent test), during ongoing dasatinib or nilotinib therapy; OR 4. Development of accelerated phase or blast crisis in a patient previously prescribed dasatinib or nilotinib for any phase of chronic myeloid leukaemia; OR 5. Disease progression (defined as a greater than or equal to 50% increase in peripheral white blood cell count, blast count, basophils or platelets) during dasatinib or nilotinib therapy in patients with accelerated phase or blast crisis chronic myeloid leukaemia. Accelerated phase is defined by the presence of 1 or more of the following: 1. Percentage of blasts in the peripheral blood or bone marrow greater than or equal to 15% but less than 30%; or 2. Percentage of blasts plus promyelocytes in the peripheral blood or bone marrow greater than or equal to 30%, provided that blast count is less than 30%; or 3. Peripheral basophils greater than or equal to 20%; or 4. Progressive splenomegaly to a size greater than or equal to 10 cm below the left costal margin to be confirmed on 2 occasions at least 4 weeks apart, or a greater than or equal to 50% increase in size below the left costal margin over 4 weeks; or 5. Karyotypic evolution (chromosomal abnormalities in addition to a single Philadelphia chromosome). Blast crisis is defined as either: 1. Percentage of blasts in the peripheral blood or bone marrow greater than or equal to 30%; or 2. Extramedullary involvement other than spleen and liver. The authority application must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail and must include: (i) details (date, unique identifying number/code or provider number) of a bone marrow biopsy pathology report demonstrating the patient has active chronic myeloid leukaemia, either manifest as cytogenetic evidence of the Philadelphia chromosome; or (ii) details (date, unique identifying number/code or provider number) of a bone marrow biopsy/peripheral blood pathology report demonstrating RT-PCR level of BCR-ABL transcript greater than 0.1% on the international scale; and (iii) where there has been a loss of response to dasatinib or nilotinib, details (date, unique identifying number/code or provider number) of the confirming pathology report(s) from an Approved Pathology Authority or details of the dates of assessment in the case of progressive splenomegaly or extramedullary involvement. All reports must be documented in the patient's medical records If the application is submitted through HPOS form upload or mail, it must include: (i) details of the proposed prescription; and (ii) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). Up to a maximum of 18 months of treatment may be authorised under this initial restriction.
Acute lymphoblastic leukaemia Clinical criteria: Treatment Phase: Initial treatment The treatment must be the sole PBS-subsidised therapy for this condition, AND Patient must be expressing the T315I mutation, AND Patient must have failed treatment with chemotherapy, with or without another tyrosine kinase inhibitor, AND Patient must have failed allogeneic haemopoietic stem cell transplantation (where appropriate). Treatment criteria: Must be treated by a medical practitioner. Failure of treatment is defined as either: 1. Failure to achieve a complete morphological and cytogenetic remission after a minimum of 2 months treatment with intensive chemotherapy, with or without another tyrosine kinase inhibitor; 2. Morphological or cytogenetic relapse of leukaemia after achieving a complete remission induced by chemotherapy, with or without another tyrosine kinase inhibitor; 3. Morphological or cytogenetic relapse or persistence of leukaemia after allogeneic haemopoietic stem cell transplantation. Patients must have active leukaemia, as defined by presence on current pathology assessments of either morphological infiltration of the bone marrow (greater than 5% lymphoblasts) or cerebrospinal fluid or other sites; OR the presence of cells bearing the Philadelphia chromosome on cytogenetic or FISH analysis in the bone marrow of patients in morphological remission. The authority application must be made in writing and must include: 1. details of the proposed prescription; and 2. a completed Acute Lymphoblastic Leukaemia - ponatinib Initial PBS authority application form; and 3. a signed patient acknowledgement; and 4. a pathology report demonstrating that the patient has active acute lymphoblastic leukaemia, either manifest as cytogenetic evidence of the Philadelphia chromosome, or morphological evidence of acute lymphoblastic leukaemia plus qualitative RT-PCR evidence of BCR-ABL transcript; and evidence of the T315I mutation. The date of the relevant pathology report(s), which should be within the previous 6 months, need(s) to be provided.
“The primary target for ponatinib is BCR-ABL, an abnormal tyrosine kinase that is the hallmark of chronic myeloid leukemia and Philadelphia-positive acute lymphoblastic leukemia. Chronic myeloid leukemia is characterized by an excessive and unregulated production of white blood cells by the bone marrow due to a genetic abnormality that produces the BCR-ABL protein. After a chronic phase of production of too many white blood cells, chronic myeloid leukemia typically evolves to more aggressive phases such as accelerated or blast crisis. Philadelphia-positive acute lymphoblastic leukemia is a subtype of acute lymphoblastic leukemia that carries the Ph+ chromosome that produces BCR-ABL. It has a more aggressive course than chronic myeloid leukemia and is often treated with a combination of chemotherapy and tyrosine kinase inhibitors. Because both of these diseases express the BCR-ABL protein, this would render them potentially susceptible to treatment with ponatinib. BCR-ABL is detected in 95% of patients with chronic myeloid leukemia.[citation needed]”
“12–66 hours”
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