Sprycel is a cancer medicine. It is used to treat adults with the following types of leukaemia....chronic myeloid leukaemia (CML) in the ‘chronic’ phase in newly diagnosed patients who are ‘Philadelphia chromosome positive’ (Ph+)….CML in ‘chronic’, ‘accelerated’ and ‘blast’ phases….newly diagnosed Ph+ CML in the ‘chronic’ phase, or Ph+ CML when other treatments including imatinib cannot be given or have not worked.

SPRYCEL is a kinase inhibitor indicated for the treatment of...newly diagnosed adults with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase….adults with chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib....pediatric patients 1 year of age and older with Ph+ CML in chronic phase.

...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.

...Patients who do not have a standard BCR-ABL1 fusion transcript (i.e. other than e13a2 or e14a2, also known as b2a2 and b3a2) are eligible, but before screening the patient, contact should be made with Prof Foroni at Imperial College (see contacts) since specialised quantitative molecular assessment will be required....

...a) Must demonstrate a quantifiable BCR-ABL1 fusion transcript on molecular studies, reported on the international scale; and...

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.

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%).

BCR-ABL-positive CML-CP patients with ≥3 years of frontline DAS and sustained MR...The median duration of DAS treatment was 51 months (36–129 months), and the median duration of MR4.5 (BCR-ABL1IS ≤0.0032%) was 30 months (24–64 months)...JALSG D-STOP216 provides prospective TFR data in Japanese patients with CML-CP who achieved sustained MR4.5 on frontline DAS.

To evaluate long-term real-life results of dasatinib therapy among chronic phase chronic myeloid leukemia patients resistant or intolerant to imatinib, we retrospectively analyzed data of 118 patients...Both OS and EFS were significantly improved among patients with BCR-ABL1 transcript level ≤10% at 3 months.

Here we report molecular features of a patient with Ph + CML who developed Ph-negative AML after showing a major molecular response to dasatinib.

The molecular analysis showed a rare co-expression of the p210 BCR-ABL1 and p195 BCR-ABL1...R-HyperCVAD+dasatinib+intra-thecal chemotherapy was initiated. At the end of the 1st A cycle a complete response was documented.