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Association details:

Evidence:

Evidence Level:
Sensitive: A1 - Approval
New
Published date:
07/01/2013
Excerpt:
Iclusig is indicated in adult patients with:...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...
Evidence Level:
Sensitive: A1 - Approval
Source:
Excerpt:
Iclusig® (ponatinib) is 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.
Evidence Level:
Sensitive: A2 - Guideline
Source:
Excerpt:
INDUCTION REGIMENS FOR Ph-POSITIVE ALL: Other Recommended regimens…TKI + vincristine + dexamethasone…TKI options include (in alphabetical order): bosutinib, dasatinib, imanitib, nilotinib or ponatinib.
Secondary therapy:
vincristine + dexamethasone
Evidence Level:
Sensitive: C2 – Inclusion Criteria
Title:
Ponatinib With Chemotherapy in Pediatric Participants With Relapsed, Resistant, or Intolerant Philadelphia Chromosome-Positive (Ph+) Acute Lymphoblastic Leukemia (ALL) or Have the T315I Mutation
Excerpt:
...Have a diagnosis of acute lymphoblastic leukemia (ALL) or mixed phenotype acute leukemia (MPAL) with definite evidence of breakpoint cluster region- Abelson 1 (BCR-ABL1) fusion (Ph) or Ph-like ALL (USA-only) with targetable kinase-activating lesions and either (i) or (ii) as follows: (i) For non...
Trial ID:
Evidence Level:
Sensitive: C3 – Early Trials
Title:
Efficacy and safety of ponatinib for patients with Philadelphia chromosome-positive acute lymphoblastic leukemia: a case series from a single institute
Published date:
04/27/2021
Excerpt:
Three patients achieved a deep molecular response (DMR) following combined intensive treatment with ponatinib as induction chemotherapy...ponatinib at a concentration of least 30 mg exhibits anti-leukemia effects in Japanese patients with Ph + ALL.
DOI:
10.1007/s12185-021-03156-0
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:
The Impact of Smoking on Survival in Patients (Pts) with Newly Diagnosed Philadelphia Chromosome Positive (Ph+) Acute Lymphoblastic Leukemia (ALL) Treated with the Combination of Intensive Therapy with Tyrosine Kinase Inhibitor (TKI)
Published date:
11/06/2019
Excerpt:
...202 pts with newly diagnosed Ph+ALL who received the combination of intensive therapy (hyper-CVAD) with imatinib, dasatinib, or ponatinib were analyzed….Of the 76 pts who received HCVAD + ponatinib, the 5-year CRD were 63% and 93%, respectively (p=0.018); the 5-year OS rates were 23% and 91%, respectively (p<0.001).
Secondary therapy:
CVAD
DOI:
https://doi.org/10.1182/blood-2019-129396
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:
Long-Term Safety and Efficacy of Hyper-CVAD Plus Ponatinib As Frontline Therapy for Adults with Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia
Published date:
11/06/2019
Excerpt:
In pts with newly diagnosed Ph+ ALL, the combination of hyper-CVAD plus ponatinib resulted in sustained responses with a CMR rate of 84% and an estimated 5-year OS rate of 73%.
Secondary therapy:
CVAD
DOI:
https://doi.org/10.1182/blood-2019-125146
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:
A Phase 2 Trial of Ponatinib in Philadelphia Chromosome–Positive Leukemias
Excerpt:
Among 32 patients with Ph-positive ALL, 41% had a major hematologic response and 47% had a major cytogenetic response....ponatinib showed clinically significant activity in patients with CML and those with Ph-positive ALL.
DOI:
10.1056/NEJMoa1306494
Trial ID:
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