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Association details:
| Biomarker: | BCR-ABL1 fusion |
|---|---|
| Cancer: | B Acute Lymphoblastic Leukemia |
| Drug: | Iclusig (ponatinib) (Multi-tyrosine kinase inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Excerpt:
REGIMENS FOR RELAPSED OR REFRACTORY Ph-POSITIVE B-ALL…Other Recommended Regimens...TKI (dasatinib, imatinib, ponatinib, nilotinib, or bosutinib)
Source:
Title:
PHALLCON: A PHASE 3 STUDY COMPARING PONATINIB VERSUS IMATINIB IN NEWLY DIAGNOSED PH+ ALL
Published date:
05/11/2023
Excerpt:
This phase 3 open-label study randomized newly diagnosed Ph+ ALL adult patients 2:1 to receive ponatinib (30 mg once daily [QD]) or imatinib...Ponatinib was superior to imatinib in combination with reduced-intensity chemotherapy in the front-line setting for patients with Ph+ ALL, with a significantly higher MRD-neg CR rate at EOI. Ponatinib was associated with deeper and more durable responses, with a trend toward improved EFS and comparable safety vs imatinib.
Secondary therapy:
Chemotherapy
Trial ID:
Excerpt:
On March 19, 2024, the Food and Drug Administration granted accelerated approval to ponatinib (Iclusig, Takeda Pharmaceuticals U.S.A., Inc.) with chemotherapy for adult patients with newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL).
Source:
Title:
4537 The Real-World Outcomes of Ponatinib in 724 Patients with CML and Ph+ ALL : A Post-Marketing Surveillance Study with a Special Interest in Arterial Occlusive Events in Japan
Published date:
11/02/2023
Excerpt:
In patients with Ph+ ALL, the CCyR rates at weeks 0, 12, 24, 52, and 104 were 35.4% (51/144), 77.1% (108/140), 73.6% (53/72), 83.6% (46/55), and 80.0% (36/45), respectively….This two-year post-marketing surveillance of patients with r/i CML and r/r Ph+ ALL has demonstrated the general favorable safety and efficacy of ponatinib to patients in Japan.
Source:
Title:
4247 Consolidation with Ponatinib Plus Sequential Blinatumomab and Chemotherapy after Low Intensity Dasatinib-Based Induction in Adults with Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia: Outcomes from a Single Institution
Published date:
11/02/2023
Excerpt:
From 6/2021-02/2023, 14 patients (median age 54) with newly diagnosed Ph+ ALL were switched to ponatinib after dasatinib + prednisone induction….Comparing outcomes between the two cohorts, relapse-free survival is improved in the more recent (ponatinib) cohort compared to the earlier (dasatinib/SCT) cohort (p=0.044, log-rank test)...For adults with Ph+ ALL, switching to ponatinib after dasatinib-based induction and consolidating with blina and chemotherapy is a safe and potentially effective strategy.
Source:
Title:
A Comprehensive Cancer Center Experience with Hyper-CVAD Plus Ponatinib As Frontline Therapy for Adult Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia
Published date:
11/04/2021
Excerpt:
We identified 13 Ph+ ALL patients who received ponatinib + hyper-CVAD for initial induction….The 3-year OS and EFS with ponatinib + hyper-CVAD were each 92% (95% confidence interval, 78.9-100) (Figure 1). Landmark analysis completed 6 months following CR showed a 3-year OS of 100% in patients treated with ponatinib + hyper-CVAD without HCT in first CR (CR1)....To our knowledge, this is the first report externally validating the efficacy and tolerability of ponatinib + hyper-CVAD for Ph+ ALL.
