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European Approval for SPRYCEL(R) (dasatinib) in Adult Patients With Newly Diagnosed CML: First New Approved Treatment in the E.U. With Superior Efficacy vs. Imatinib Since 2001

Paris (ots/PRNewswire)

Bristol-Myers Squibb today
announced that SPRYCEL(R) (dasatinib) 100mg once daily received
Marketing Authorization from the European Commission for the
treatment of adult patients with newly diagnosed Philadelphia
chromosome positive (Ph+) Chronic Myelogenous Leukaemia in Chronic
Phase (CML-CP). Sprycel is the first new approved treatment in the
E.U. with superior efficacy vs. imatinib in this indication since
2001. The authorization is based on results from the DASISION
(Dasatinib versus Imatinib Study in Treatment-Naïve CP-CML Patients)
open-label, Phase 3 trial, which were 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 The New England Journal of Medicine in June 2010.[1] The trial is
ongoing and further data will be required to determine long-term
outcomes.
"The Marketing Authorization by the European Commission is an
important development for CML patients and their physicians in Europe
who now have an option that has both improved response over imatinib
and offers a once-daily dosing convenience with no fasting
requirements," said Elliott Sigal, Executive Vice President, CSO &
President, R&D, Bristol-Myers Squibb. "Data from the DASISION trial
demonstrated that newly diagnosed patients with Philadelphia
chromosome positive CML in chronic phase who received dasatinib
attained higher and faster molecular and confirmed complete
cytogenetic response rates by 12 months compared to imatinib."
Lead DASISION investigator Professor Michele Baccarani,
University of Bologna, Italy commented: "The profile of CML, one of
the four most common types of leukaemia, has changed dramatically in
recent years with the introduction of targeted therapies; its
prevalence is growing as patients live longer. The European Marketing
Authorization and results of the DASISION study confirm the role of
dasatinib as an option in the frontline treatment of Philadelphia
positive chronic myelogenous leukaemia."
Dasatinib Demonstrated Superior Response Rates Compared to
imatinib[1]
In the DASISION study, dasatinib demonstrated superior efficacy
with higher and faster molecular and confirmed cytogenetic response
rates compared to imatinib by 12 months in newly diagnosed CP-CML
patients. Seventy-seven percent [95% CI: 71- 82] of dasatinib
patients vs. 66% [95% CI: 60 - 72] of imatinib patients achieved the
primary endpoint of confirmed CCyR (two consecutive assessments of
CCyR at least 28 days apart) by 12 months (p=0.007). Median time to
confirmed CCyR was 3.1 months in 199 dasatinib responders and 5.6
months in 177 imatinib responders. Median time to major molecular
response[iii] (MMR) was 6.3 months in 135 dasatinib responders and
9.2 months in 88 imatinib responders. MMR at anytime was higher for
dasatinib patients (52% [95% CI: 45 - 58]) versus imatinib (34% [95%
CI: 28 - 40]), p<0.0001.[iv] Transformation to accelerated or blast
phase occurred in 5 patients receiving dasatinib and 9 patients
receiving imatinib.
Commonly reported adverse events (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 the DASISION Study
DASISION (Dasatinib versus Imatinib Study in Treatment-Naïve
CP-CML Patients) is an open-label, randomized, Phase 3 international
trial of dasatinib 100mg taken once daily vs. imatinib 400mg taken
once daily, in the treatment of newly diagnosed chronic phase Ph+
CML. The study enrolled 519 patients; 259 patients were randomized to
receive dasatinib and 260 patients were randomized to receive
imatinib. The primary study endpoint was the rate of confirmed CCyR
by 12 months. Secondary endpoints included time-to confirmed CCyR,
major molecular response (MMR) rate and time-to MMR.
About SPRYCEL(R) (dasatinib)[v]
Dasatinib, an oral BCR-ABL inhibitor, was initially approved in
November 2006 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. Dasatinib 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.[2] 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 and Otsuka Pharmaceutical Co., Ltd.
Bristol-Myers Squibb and Otsuka Pharmaceutical Co., Ltd. are
collaborative partners in the commercialization of SPRYCEL in the
United States, and in Japan. SPRYCEL was discovered and developed by
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.
Founded in 1964, Otsuka Pharmaceutical Co., Ltd. is a global
healthcare company with the corporate philosophy: 'Otsuka-people
creating new products for better health worldwide.' Otsuka
researches, develops, manufactures and markets innovative and
original products, with a focus on pharmaceutical products for the
treatment of diseases and consumer products for the maintenance of
everyday health.
    References
    [1] Kantarjian H, et al. N Engl J Med. 2010 Jun 17;362(24):2260-70.
    [2] Baccarani, M. and Dreyling, M. Annals of Oncology. 2010;21:165-167
[i] Newly Diagnosed Philadelphia Chromosome Positive Chronic
Myelogenous Leukaemia in Chronic Phase
[ii] Complete cytogenetic response (CCyR) is defined as the
absence of Philadelphia chromosome-positive metaphases on cytogenetic
assessment of bone marrow cells.
[iii] 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.
[iv] Adjusted for Hasford Score and indicated statistical
significance at a pre-defined nominal level of significance
[v] For full information on SPRYCEL (dasatinib) please refer to
SmPC at: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/
human/medicines/000709/smops/Positive/human_smop_000147.jsp&murl=menu
s/medicines/medicines.jsp&mid=WC0b01ac058001d127
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Contact:

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

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