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SPRYCEL(R) (dasatinib) Receives CHMP Positive Opinion for the Treatment of Adult Patients With Newly Diagnosed Philadelphia Chromosome Positive Chronic Myelogenous Leukaemia in Chronic Phase

Paris (ots/PRNewswire)

Bristol-Myers Squibb today
announced that SPRYCEL(r) (dasatinib) received a positive opinion
from the Committee for Medicinal Products for Human Use (CHMP) for
the treatment of adult patients with newly diagnosed Philadelphia
chromosome positive Chronic Myelogenous Leukaemia in Chronic Phase
(CML-CP). This decision follows the presentation of results from the
pivotal DASISION study in which dasatinib 100 mg once daily
demonstrated a superior rate of confirmed complete cytogenetic
response (CCyR)[*] compared to imatinib by 12 months in chronic phase
CML patients. The data was presented as a late-breaking abstract at
the 46th Annual Meeting of the American Society of Clinical Oncology,
during the Best Abstracts section of the Presidential Symposium at
the 15th Congress of the EHA and published in New England Journal of
Medicine in June 2010.
The European Medicines Agency's (EMA) CHMP adopted the positive
opinion based on the 12 month results from the DASISION trial. The
European Commission generally grants the Marketing Authorization
within three months of a positive CHMP opinion.
Commenting on the developments BMS spokesperson Renzo Canetta,
Vice-President, Oncology Global Clinical Research, said:
"Bristol-Myers Squibb is committed to working together with
regulatory authorities in different countries around the world to
help ensure that CML patients and their physicians are provided with
treatment options that can achieve optimal outcomes for their
patients whether they are newly diagnosed or resistant or intolerant
to previous treatment."
DASISION Study Results
In the ongoing DASISION (Dasatinib versus Imatinib Study in
Treatment-Naïve CP-CML Patients) study, results of which were
published in the NEJM in June 2010,[1] 77% of patients in the
dasatinib arm vs. 66% of patients in the imatinib arm achieved
confirmed CCyR (two consecutive assessments of CCyR) within 12 months
(p=0.007). Additionally, 83% of dasatinib patients vs. 72% of
imatinib patients achieved CCyR by one year (p=0.001). The time to
CCyR was shorter for dasatinib patients than imatinib patients
(hazard ratio = 1.5, p<0.0001), with more than half of dasatinib
patients (54%) achieving CCyR within three months. Dasatinib patients
were also twice as likely as imatinib patients to achieve a major
molecular response[**] (MMR), a more sensitive method of assessment
of treatment response,[2,3] during the course of the study (hazard
ratio = 2.0, p<0.0001).
Commonly reported adverse events[1] (of all grades) with
dasatinib and imatinib respectively included superficial oedema (9%
and 36%), pleural effusions (10% and 0%), nausea (8% and 20%), rash
(11% and 17%) and muscle inflammation (4% and 17%).
About SPRYCEL (dasatinib)
Dasatinib, an oral BCR-ABL inhibitor, is currently approved by
the European Commission for the treatment of adults for all phases of
CML (chronic, accelerated, or myeloid or lymphoid blast phase) with
resistance or intolerance to prior therapy including imatinib.
SPRYCEL is also approved for the treatment of adults with
Philadelphia chromosome-positive acute lymphoblastic leukemia with
resistance or intolerance to prior therapy.
The active ingredient of SPRYCEL is dasatinib. At nanomolar
concentrations, dasatinib reduces the activity of one or more
proteins responsible for the uncontrolled growth of the leukemia
cells of patients with CML or Ph+ ALL.
About Chronic Myelogenous (or Myeloid) Leukemia (CML)
CML is a slow-growing type of leukemia in which the body produces
an uncontrolled number of abnormal white blood cells. CML is most
commonly diagnosed in those aged 60-65 and the incidence is estimated
at 1-2 cases per 100,000.[4] CML occurs when pieces of two different
chromosomes break off and attach to each other. The new chromosome is
called the Philadelphia-positive chromosome, which contains an
abnormal gene called BCR-ABL that signals cells to make too many
white blood cells. There is no known cause for the genetic change
that causes CML.
About Bristol-Myers Squibb
Bristol-Myers Squibb is a global biopharmaceutical company whose
mission is to discover, develop and deliver innovative medicines that
help patients prevail against serious diseases. Around the world, our
medicines are helping millions of patients in their fight against
such diseases as cancer, heart disease, HIV/AIDS, psychiatric
disorders, rheumatoid arthritis, chronic hepatitis B virus infection
and diabetes.
    References
    1. Kantarjian H, et al. N Engl J Med. 2010 Jun 17;362(24):2260-70.
    2. Branford S. Hematology. 2007:376-83.
    3. Hughes T, et al. Blood. 2006;108:28-37
    4. Baccarani, M. and Dreyling, M. Annals of Oncology. 2010;21:165-167
[*] Complete cytogenetic response (CCyR) is defined as the
absence of Philadelphia chromosome-positive metaphases on cytogenetic
assessment of bone marrow cells.
[**] Major molecular response (MMR) is defined as a BCR-ABL
transcript level of [less than or equal to]0.1% (3 log reduction) as
measured by  real-time quantitative polymerase chain reaction
(RQ-PCR) of peripheral  blood.
Contacts:
    Bristol-Myers Squibb,
    European Media Contact:
    Elzbieta Zawislak, +33615523580,  elzbieta.zawislak@bms.com .

Contact:

CONTACT: Contacts: Bristol-Myers Squibb, European Media Contact:
ElzbietaZawislak, +33615523580, elzbieta.zawislak@bms.com .

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