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Dasatinib
API
(DMF filed) |
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Haorui supplies high quality Dasatinib API produced by our
GMP facility that has been successfully inspected by the
FDA.
We offer
competitive prices and support our products with reliable technical and
regulatory services. Dasatinib API is available from R&D to
commercial quantities. Please contact us for more details. |
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The following
information is provided for general information purposes
ONLY. |
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What is Dasatinib? |
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Dasatinib, also known as BMS-354825, is a drug produced by
Bristol-Myers Squibb and sold under the trade name Sprycel®.
Dasatinib is an oral dual BCR/ABL and Src family tyrosine
kinases inhibitor approved for use in patients with chronic
myelogenous leukemia (CML) after imatinib treatemant and
Philadelphia chromosome-positive acute lymphoblastic
leukemia (Ph+ ALL). It is also being assessed for use in
metastatic melanoma. The drug is named after the inventor
chemist, Jagabandhu Das, who codiscovered it while working
at Bristol Myers Squibb. |
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Efficacy of
Dasatinib |
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In a Phase I dose escalation study published in June 2006,
dasatinib was tested in patients who were resistant to or
who could not tolerate imatinib (Talpaz et al., 2006).
Complete hematological responses were seen in 37 of 40
patients with chronic-phase CML. Major hematologic responses were seen in 31 of 44 patients with
accelerated-phase CML, CML in blast crisis, or Ph+ ALL. |
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Molecular Targets of
Dasatinib |
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The main targets of Dasatinib, are BCRABL, SRC, Ephrins, GFR. |
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Duration of benefit |
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Responses were maintained in 95% of patients with
chronic-phase CML, with a median follow-up time of >12
months. In patients with accelerated-phase CML, 82% remained
in remission, although with a median follow-up of only 5
months. Nearly all patients with CML in blast crisis or Ph+
ALL relapsed within 6 months. |
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Susceptible genotypes of
Dasatinib |
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Responses were seen in patients with all BCR/ABL genotypes,
with the exception of T315I mutation, which confers
resistance to both dasatinib and imatinib in vitro. |
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Toxicities of
Dasatinib |
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Neutropenia and myelosuppression were common toxic effects.
Fifteen patients in the above-mentioned study developed
pleural effusions, which were felt to be a side effect of
dasatinib. Some of these patients required thoracentesis or
pleurodesis to treat the effusions. Other adverse events
included mild to moderate diarrhea, peripheral edema, and
headache. A small number of patients developed abnormal
liver function tests which returned to normal without dose
adjustments. Mild hypocalcemia was also noted, but did not
appear to cause any significant problems. |
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Disclaimer:
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Information on this page is provided for
general information purposes. You should not make a clinical
treatment decision based on information contained in this
page without consulting other references including the
package insert of the drug, textbooks and where relevant,
expert opinion. We cannot be held responsible for any errors
you make in administering drugs mentioned on this page, nor
for use of any erroneous information contained on this
page. |
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