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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. 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
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. 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.
 Kantarjian H, et al. N Engl J Med. 2010 Jun 17;362(24):2260-70.
 Baccarani, M. and Dreyling, M. Annals of Oncology. 2010;21:165-167@@end@@
[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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