^
Association details:
Evidence:
Evidence Level:
Sensitive: A1 - Approval
New
Excerpt:
Tasigna is indicated for the treatment of:...adult and paediatric patients with newly diagnosed Philadelphia chromosome positive chronic myelogenous leukaemia (CML) in the chronic phase…
Evidence Level:
Sensitive: A1 - Approval
New
Source:
Excerpt:
Tasigna is a kinase inhibitor indicated for the treatment of:...Adult and pediatric patients greater than or equal to 1 year of age with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase...Pediatric patients greater than or equal to 1 year of age with Ph+ CML-CP and CML-AP resistant or intolerant to prior tyrosine-kinase inhibitor (TKI) therapy.
Evidence Level:
Sensitive: B - Late Trials
Source:
Title:

1665 Effectiveness of Second-Line (2L) Tyrosine Kinase Inhibitor (TKI) Therapy after Resistance or Intolerance to a Prior TKI in Patients with Philadelphia Chromosome–Positive Chronic Myeloid Leukemia in Chronic Phase (Ph+ CML-CP)

Published date:
11/04/2020
Excerpt:
CONTRADICTING EVIDENCE:...pts diagnosed with Ph+ CML-CP who were initiated on a 2G TKI (dasatinib, nilotinib, or bosutinib) as 2L therapy...In 2L TKI therapy, 41% of pts received nilotinib, 19% dasatinib, and 40% bosutinib...Although 2G TKIs have higher efficacy and lower progression rates in 1L vs 1G TKI, a substantial proportion of pts still do not achieve the important treatment response milestones; almost 50% did not achieve MMR within 12 months of 2L TKI therapy.
Evidence Level:
Sensitive: B - Late Trials
New
Title:

Durable treatment-free remission in patients with chronic myeloid leukemia in chronic phase following frontline nilotinib: 96-week update of the ENESTfreedom study

Excerpt:
Patients consistently in MR4.5 during consolidation had higher TFR rates (50.6%) than patients with ≥ 1 assessment without MR4.5 during consolidation (35.0%). In a landmark analysis, 96-week TFR rates for patients with MR4.5, MR4 (BCR-ABL1IS ≤ 0.01%) but not MR4.5, and MMR but not MR4 at TFR week 12 were 82.6, 23.1, and 0%, respectively. There were no reports of disease progression or death due to CML; overall adverse event frequency decreased following TFR. Within the follow-up period, TFR did not adversely affect disease outcomes.
DOI:
10.1007/s00432-018-2604-x
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

Efficacy and Safety of Nilotinib in CML-CP

Excerpt:
...Cumulative rate of BCR-ABL1 fusion transcripts ≤ 0.0032%, measured by real-time quantitative polymerase chain reaction and standardized to the international scale`Cumulative rate of molecular response 4.5 by 24 months...
Trial ID:
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

The long-term efficacy and safety of nilotinib in pediatric patients with CML: a 5-year update of the DIALOG study

Published date:
12/12/2023
Excerpt:
The safety profile of nilotinib was consistent with those of earlier reports. No on-treatment deaths occurred. These long-term (up to ∼5 years) data support the efficacy and safety of nilotinib in pediatric patients with Ph+ CML-CP.
DOI:
10.1182/bloodadvances.2023010122
Trial ID:
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

EPIDEMIOLOGICAL, CLINICAL AND THERAPEUTIC FEATURES OF CHRONIC MYELOID LEUKEMIA : EXPERIENCE OF FATTOUMA BOURGUIBA HOSPITAL OF MONASTIR

Published date:
05/11/2023
Excerpt:
We conducted a retrospective study including patients treated for CML between 2003 and 2021….BCR-ABL1 transcript was detected at diagnosis by Reverse Transcriptase-Polymerase Chain Reaction....Second line therapy with second generation TKIs (Dasatinib or Nilotinib) was required in 35% of cases due to the treatment failure in 32% and treatment related toxicity in 3% of cases. DMR was reported in 78% of cases....Our study showed that TKIs first and second generation are highly effective in the treatment of CML, achieving complete hematological response and high rates of molecular response and leading to good long-term outcomes for patients.
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

TREATMENT-FREE REMISSION IN PATIENTS WITH CHRONIC MYELOID LEUKEMIA IN CHRONIC PHASE FOLLOWING FRONTLINE NILOTINIB: RESULTS FROM JALSG N-STOP216

Published date:
05/12/2021
Excerpt:
BCR-ABL-positive CML-CP patients with ≥3 years of frontline NIL...At 12 months, 37/51 patients remained in MR4.0 (BCR-ABL1IS ≤0.01%) (72.6%; 95% CI:58.3%–84.1%); 14 patients (27.5%) lost MR4.0, and 31/51 patients remained in MR4.5 (60.8%; 95% CI:46.1%–74.2%); 20 patients (39.2%) lost MR4.5. No patient experienced disease progression...
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

A MULTICENTER REAL-WORD EVIDENCE STUDY IN THE SWISS TREATMENT LANDSCAPE OF CHRONIC MYELOID LEUKEMIA

Published date:
05/12/2021
Excerpt:
Data from 63 patients treated with TKIs were collected (first-line imatinib [n = 27], nilotinib [n = 27], dasatinib [n = 8], or ponatinib [n = 1]). A higher percentage of patients in the nilotinib and dasatinib groups versus the imatinib group reached a deep molecular response (BCR-ABL1IS ≤ 0.01%) at 12 months (32% and 25%, respectively, vs. 23%) and 18 months (42% and 38%, respectively, vs 27%).
Evidence Level:
Sensitive: C3 – Early Trials
New
Source:
Title:

Phase 2 study of nilotinib in pediatric patients with Philadelphia chromosome–positive chronic myeloid leukemia

Excerpt:
...nilotinib demonstrated efficacy and a manageable safety profile in pediatric patients with Ph+ CML-CP.
DOI:
10.1182/blood.2019000069
Trial ID:
Evidence Level:
Sensitive: C3 – Early Trials
New
Title:

Nilotinib in Imatinib-Resistant CML and Philadelphia Chromosome–Positive ALL

Excerpt:
At three centers, from May 25, 2004, to May 4, 2005, we enrolled 119 patients whose disease was resistant to imatinib... As of June 15, 2005, 66 patients remained in the study, including all 17 patients with chronic-phase CML….Among 17 patients with the chronic phase of disease, the median duration of therapy was 4.9 months...and all of the patients have continued therapy. At the present time, 11 of 12 patients with active disease have had a complete hematologic remission. There were cytogenetic responses in 9 of 17 patients who could be evaluated, including 6 responses that were complete... All trough levels exceeded the 50 percent inhibitory concentration of cellular phosphorylation of BCR-ABL (20 to 57 nM, depending on cell type) and 32 of 33 BCR-ABL kinase mutants (19 to 709 nM)…nilotinib has a relatively favorable safety profile, and preliminary results obtained with a relatively short follow-up period indicate that the drug is active in CML.
DOI:
10.1056/NEJMoa055104
Trial ID:
Evidence Level:
Sensitive: C4 – Case Studies
Source:
Title:

CML-357- Jumping Out of the Frying Pan, Into the Fire: Case Report of Secondary Non-Hodgkin Lymphoma (NHL) in a Case of Chronic Myeloid Leukemia (CML)

Published date:
09/21/2022
Excerpt:
A 58-year-old female...was diagnosed as CML based on blood film, bone marrow aspiration, and biopsy results and was confirmed by the detection of Philadelphia chromosome P210 in 46% of cells….She was shifted to nilotinib with the absence of the previous toxicities and QPCR reduction....PET- CT was negative after four cycles, and QPCR remained undetectable. Therefore, the patient is continuing nilotinib with regular monthly follow-up for lymph node ultrasonography.
Evidence Level:
Sensitive: C4 – Case Studies
Title:

Dasatinib associated lymphadenopathy in a chronic myeloid leukemia patient: A case report

Published date:
11/06/2020
Excerpt:
A 40-year-old male patient was diagnosed with BCR-ABL1 positive chronic stage CML 2 years ago and achieved complete molecular response on nilotinib...
DOI:
10.1097/MD.0000000000022791