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SPRYCEL(TM) (Dasatinib) Approved in Europe - the First Significant Advance for Treatment-Resistant CML and Ph+ ALL Leukaemia Patients in Five Years

Paris, November 22 (ots/PRNewswire)

- New Hope for CML and Ph+ ALL Patients who Face Resistance or
Intolerance to Current Therapies
For Non-US Journalists Only
Today, the European Commission approved SPRYCEL(TM) (dasatinib,
formerly known as BMS-354825) for the treatment of adults with
chronic, accelerated or blast phase chronic myeloid leukaemia (CML)
with resistance or intolerance to prior therapy, including imatinib
mesylate. SPRYCEL is also indicated for the treatment of adults with
Philadelphia chromosome positive (Ph+) acute lymphoblastic leukaemia
(ALL) and lymphoid blast CML with resistance or intolerance to prior
therapy.
SPRYCEL, which has been granted orphan drug status, received rapid
approval from regulatory authorities in Europe. In June 2006, the
U.S. Food and Drug Administration granted accelerated approval to
SPRYCEL for CML with resistance, or intolerance, to prior therapies
and approval for Ph+ ALL with resistance or intolerance to prior
therapies.
For patients with CML or Ph+ ALL, the development of resistance or
intolerance to standard treatment can be a devastating event. The
potential for drug resistance to develop may increase with length of
prior treatment and the stage of disease. Emerging evidence from a
single European centre study indicates that resistance to imatinib
mesylate may occur in approximately 25% of chronic phase CML
patients, 41% of accelerated phase patients and 92% of blast crisis
patients.(1) Until today, limited  therapeutic options have been
available to these patients.
"SPRYCEL was discovered and has been developed by Bristol-Myers
Squibb scientists to help CML and Ph+ ALL patients who face a serious
problem of resistance or intolerance to the current standard
treatment," said Beatrice Cazala, president, Europe, Middle East and
Africa for Bristol-Myers Squibb. "With the approval of SPRYCEL in
Europe, these patients now have an effective therapeutic option that
can overcome treatment resistance and intolerance in certain cases."
Resistance to therapy is thought to involve the following
mechanisms:(2)
  • mutations of Bcr-Abl, the key protein responsible for CML and Ph+ ALL
  • overexpression of Bcr-Abl
  • other proteins involved in cancer pathways, such as the Src pathway,
which is thought to play a role in CML and Ph+ ALL as well as
other cancers.
Mutations can change the shape of the Bcr-Abl protein. When this
happens, imatinib mesylate, the current standard treatment, may be
unable to block its activity. SPRYCEL is an oral, multi-targeted
therapy that can inhibit the action of Bcr-Abl in the presence of all
but one known mutation.(3,4)
Professor François Guilhot, Professor of Haematology, Director of
the Clinical Research Centre, University Hospital La Miletrie,
Poitiers, France; President of the French Chronic Myelogenous
Leukemia Group commented: "Initial clinical trials demonstrate that
SPRYCEL can affect leukaemic cell growth enabling many adults with
CML or Ph+ ALL to control their disease over a sustained period of
time. In a Phase II study, SPRYCEL demonstrated significant
haematological and cytogenetic efficacy in imatinib
mesylate-resistant and -intolerant CML patients in chronic phase;
moreover, in the majority of patients with chronic phase CML who had
become resistant to standard therapy, responses were durable. It is
worth noting that as early as in the Phase I study, haematologic and
cytogenetic responses were observed in all phases of CML and in Ph+
ALL in the first 84 patients treated and followed for up to 19
months. Responses were durable across all phases of CML and Ph+ ALL."
The European Medicines Agency reviewed the efficacy and safety of
SPRYCEL based on the analysis of five Phase II multi-centre studies
in patients with resistance or intolerance to imatinib mesylate in
all phases of CML or Ph+ ALL.(2) The studies were conducted on five
continents (33 countries) and SPRYCEL was shown to have a predictable
and manageable side-effect profile. In the 911 patients receiving
SPRYCEL in clinical trials, the most common side effects were fluid
retention (including pleural effusion and peripheral oedema),
gastrointestinal (diarrhoea, nausea and vomiting), skin rash,
headache, haemorrhage, fatigue, and dyspnoea (difficulty in
breathing).
Myelosuppression (a reduction in blood-cell production by the bone
marrow) was reported in all studies and was generally reversible. The
frequency was higher in patients with advanced CML or Ph+ ALL than in
chronic phase CML.(2)
Full SPRYCEL Product Information and the European Public
Assessment Report (EPAR) will be available at www.emea.europa.eu
SPRYCEL is available in Austria, Germany, France, Finland, Sweden
and the United Kingdom. Availability in other European countries is
subject to individual country regulations, including pricing and
reimbursement laws.
About Bristol-Myers Squibb
Bristol-Myers Squibb is dedicated to the discovery, development
and exhaustive exploration of innovative cancer-fighting therapies
that extend and enhance the lives of patients living with cancer.
More than 40 years ago, Bristol-Myers Squibb built a unified vision
for the future of cancer treatment. With expertise, dedication and
resolve, that vision led to the development of a diverse global
portfolio of anti-cancer therapies that are an important cornerstone
of care today. Hundreds of scientists at Bristol-Myers Squibb's
Pharmaceutical Research Institute are studying ways to improve
current cancer treatments and identify better, more effective
medicines for the future.
Bristol-Myers Squibb is a global pharmaceutical and related health
care products company whose mission is to extend and enhance human
life.
REFERENCES
1. Lahaye T, Riehm B, Berger U et al. Cancer 2005;103:1659-69.
2. SPRYCEL(TM) Summary of Product Characteristics.
3. Talpaz M, Shah NP, Kantarijian H et al. N Engl J Med
2006;354:2531-41
4. O'Hare T, Walters DK, Stoffregen EP et al. Cancer Res
2005;65:4500-5

Contact:

Media contacts: Yvette Venable, Bristol-Myers Squibb, Tel:
+33-1-58-83-81-89, Mobile: +33-6-31-43-76-26, Email:
yvette.venable@bms.com

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