DASATINIB (SPRYCEL)
- Dasatinib (Sprycel) is 325-fold and 16-fold more potent than Gleevec and Tasigna in the
laboratory. - It was approved by the FDA in 2006 as second-line CML therapy for patients resistant and
intolerant to Gleevec. The current approved dose is 100mg once a day for chronic phase CML
and 140mg a day for advanced phase CML. - From data to be presented at the 13th Congress of the European Hematology Association in
2008, the Phase I Sprycel trials on 45 late chronic phase patients resistant or intolerant to
Gleevec show a 82% overall survival rate and a 64% progression-free survival rate at the 3-year
follow-up. Progression-free survival was 87% for those who achieved a major cytogenetic
remission any time on Sprycel. 62% of patients remain on Dasatinib. - In the Phase II Start-C trials of chronic phase patients with a follow-up of 2 years and 288
Gleevec-resistant and 99 Gleevec-intolerant patients, 91% achieved a CHR, 62% achieved a
MCR and 53% achieved a CCR with a MMR in 47% of patients. In Gleevec intolerant patients,
the CCR and MMR rate was 78%. MCRs were durable with 88% maintaining response at 24
months. Progression-free survival at 2 years was 80% and overall survival 94%. - In a trial comparing 800mg Gleevec to 70mg twice a day Sprycel for Gleevec-resistant patients,
the CCR rates at 2 years is 44% on Sprycel versus 18% on Gleevec. 90% of Sprycel patients
maintained MCR at 18 months versus 74% of Gleevec patients. 86% Sprycel patients had
progression-free survivals at 2 years compared to 65% of 800mg Gleevec patients. - 40 newly diagnosed patients treated with 100mg a day Sprycel showed a 100% CCR rate at the
12 month mark proving Sprycel to be very effective in debulking disease in early chronic phase.
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