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Association details:
| Biomarker: | ABL1 T315I |
|---|---|
| Cancer: | Chronic Myeloid Leukemia |
| Drug: | Iclusig (ponatinib) (Multi-tyrosine kinase inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Published date:
07/01/2013
Excerpt:
Iclusig is indicated in adult patients with:...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...
Source:
Title:
Ponatinib in Participants With Resistant Chronic Phase Chronic Myeloid Leukemia (CP-CML) to Characterize the Efficacy and Safety of a Range of Doses
Excerpt:
...and BP-CML o] Cytogenetic assessment at screening must demonstrate the BCR-ABL1 fusion by presence of the t(9;22) Philadelphia chromosome....
Trial ID:
Source:
Title:
A Phase 2 Trial of Ponatinib in Philadelphia Chromosome–Positive Leukemias
Excerpt:
Among patients with accelerated-phase CML, 55% (95% CI, 44 to 66) had a major hematologic response by 6 months (the primary end point). A major cytogenetic response was seen in 39%, 24% had a complete cytogenetic response, and 16% had a major molecular response....High response rates were observed among patients with BCR-ABL mutations, including those with the T315I mutation, and among those without BCR-ABL mutations...ponatinib showed clinically significant activity in patients with CML and those with Ph-positive ALL.
DOI:
10.1056/NEJMoa1306494
Trial ID:
