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

By Bristol-myers Squibb, PRNE
Tuesday, December 7, 2010

SPRYCEL(R) (dasatinib) Offers Physicians Additional Choice for Newly Diagnosed CML-CP[i] Patients With Once Daily Dosing Convenience With No Fasting Requirements

PARIS, December 8, 2010 - 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
, and in Japan. SPRYCEL was discovered and developed by Bristol-Myers

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.


    [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

[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:

(Due to the length of this URL, it may be necessary to copy and paste
this hyperlink into your Internet browser's URL address field. Remove the
space if one exists.)

Contact: Bristol-Myers Squibb, European Media Contact: Elzbieta Zawislak, +33615523580, elzbieta.zawislak at .

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