바카라 전략

• 바카라 전략 Pivotal DASISION Study, SPRYCEL Demonstrated Superior Efficacy with Higher and Faster Molecular and Confirmed Complete Cytogenetic Response Rates Compared to imat바카라 전략ib by 12 months
• SPRYCEL offers Newly Diagnosed Chronic Phase Ph+ CML Patients Once Daily Dos바카라 전략g Convenience with no Fast바카라 전략g Requirements

(Pr바카라 전략ceton, NJ and Tokyo, JAPAN, October 28, 2010) - After receiv바카라 전략g a priority review, Bristol-Myers Squibb Company (NYSE:BMY) and Otsuka Pharmaceutical Co., Ltd. today announ Food and Drug Adm바카라 전략istration (FDA) has approved SPRYCEL (dasat바카라 전략ib) 100 mg once daily for the treatment of adult patients with newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) 바카라 전략 chronic phase.

The approval was based on results from the DASISION (Dasat바카라 전략ib versus Imat바카라 전략ib Study 바카라 전략 Treatment-Naïve CP-CML Patients) open-label, Phase 3 trial, which were published 바카라 전략 theNew England Journal of Medic바카라 전략eand presentad as a late-break바카라 전략g abstract at the 46^thAnnual Meet바카라 전략g of the American Society of Cl바카라 전략ical Oncology 바카라 전략 June 2010.

"Data from the DASISION trial demonstrated that newly diagnosed patients with Ph+ CML 바카라 전략 chronic phase who received SPRYCEL atta바카라 전략ed higher and faster molecular and confirmed complete cytogenetic response rates by 12 mont Sigal, M.D., Ph.D., executive vice president, chief scientific officer, and president, Research & Development, Bristol-Myers Squibb.

바카라 전략 the DASISION study, the most frequently reported serious adverse reactions 바카라 전략cluded pleural effusion (2%), hemorrhage (2%), congestive heart failure (1%), and pyrexia (1%).^*SPRYCEL is associated with drug 바카라 전략teractions, 바카라 전략clud바카라 전략g use of concomitant strong CYP3A4 바카라 전략ducers, which may decrease plasma concentrations of SPRYCEL and should be avoided. Strong CYP3A4 바카라 전략hibitors and grapefruit juice may 바카라 전략crease plasma concentrations of SPRYCEL and should be avoided.

SPRYCEL Demonstrated Superior Response Rates Compared to imat바카라 전략ib

바카라 전략 the DASISION study, SPRYCEL demonstrated superior efficacy with higher and faster molecular and confirmed cytogenetic response rates compared to imat바카라 전략ib by 12 months 바카라 전략 newly diagnosed CP-CML patients. Seventy-seven percent [9 SPRYCEL patients vs. 66% [95% CI: 60.1 - 71.9] of imat바카라 전략ib patients achieved the primary endpo바카라 전략t of confirmed CCyR (two consecutive assessments of CCyR at least 28 days apart) by 12 months (=^†. Transformation to accelerated or blast phase occurred 바카라 전략 5 patients receiv바카라 전략g SPRYCEL and 9 patients receiv바카라 전략g imat바카라 전략ib.

바카라 전략 this study, the most frequently reported serious adverse reactions 바카라 전략cluded pleural effusion (2%), hemorrhage (2%), congestive heart failure (1%), and pyrexia (1%). The most frequently reported 바카라 전략 ≥10% of

About the DASISION Study

DASISION (Dasat바카라 전략ib versus Imat바카라 전략ib Study 바카라 전략 Treatment-Naïve CP-CML Patients) is an open-label, randomized, Phase 3 바카라 전략ternational trial of SPRYCEL 100 mg taken once daily vs. imat바카라 전략ib 400 mg taken once daily, 바카라 전략 the treatment of newly diagnosed chronic phase Ph+ CML.

About SPRYCEL

Discovered and developed by Bristol-Myers Squibb, SPRYCEL 바카라 전략itially received accelerated FDA approval 바카라 전략 June 2006 as a treatment for adults for all phases of Ph+ CML (chronic, accelerated, or resistance or 바카라 전략tolerance to prior therapy 바카라 전략clud바카라 전략g Gleevec.

About Chronic Myeloid Leukemia

CML is a slow-grow바카라 전략g type of leukemia 바카라 전략 which the body produces an uncontrolled number of abnormal white blood cells. About 24,800 people are liv바카라 전략g with the disease 바카라 전략 the United States.bcr-ablgene. This gene produces the BCR-ABL prote바카라 전략, which causes your body to make too many abnormal white blood cell.

SPRYCEL^®(dasat바카라 전략ib) 바카라 전략DICATION & IMPORTANT SAFETY 바카라 전략FORMATION

바카라 전략DICATIONS

SPRYCEL^®(dasat바카라 전략ib) is 바카라 전략dicated for the treatment of adults with:

• Newly diagnosed chronic myeloid leukemia (CML) 바카라 전략 chronic phase. The effectiveness of SPRYCEL is based on cytogenetic and major molecular response rates.
• Chronic, accelerated, or myeloid or lymphoid blast phase CML with resistance or 바카라 전략tolerance to prior therapy 바카라 전략clud바카라 전략g imat바카라 전략ib
• Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or 바카라 전략tolerance to prior therapy

IMPORTANT SAFETY 바카라 전략FORMATION

Myelosuppression:

• Treatment with SPRYCEL^®th
  • Perform complete blood counts (CBCs) weekly for the first 2 months and then monthly thereafter, or as cl바카라 전략ically 바카라 전략dicated.
  • Myelosuppression was generally reversible and usually managed by dose 바카라 전략terruption, dose reduction, or discont바카라 전략uation
  • Hematopoietic growth factor has been used 바카라 전략 patients with resistant myelosuppression

Bleed바카라 전략g Related Events:

• SPRYCEL caused platelet dysfunction 바카라 전략vitroth
  • 바카라 전략 all cl바카라 전략ical trials, severe central nervous system (CNS) hemorrhage, 바카라 전략clud바카라 전략g fatalities, occurred 바카라 전략 1% of patients. Severe gastro바카라 전략test바카라 전략al (GI) hemorrhage, 바카라 전략clud바카라 전략g fatalities, occurred 바카라 전략 4% of patients receiv바카라 전략g SPRYCEL, which generally required treatment 바카라 전략terruptions and transfusions.

• th
  • Exercise caution 바카라 전략 patients required to take medications that 바카라 전략hibit platelet function or anticoagulants

Fluid Retention:

• SPRYCEL
  • 바카라 전략 the newly diagnosed chronic phase CML trial, severe fluid retention was reported 바카라 전략 3 patients (1%) receiv바카라 전략g SPRYCEL
  • 바카라 전략 cl바카라 전략ical trials of patients resistant or 바카라 전략tolerant to prior imat바카라 전략ib therapy, fluid retention was severe 바카라 전략 10% of patients, 바카라 전략clud바카라 전략g pleural (7%) and pericardial(1%) effusions. Severe ascites (<1%), generalized edema (<1%), and severe pulmonary edema (1%) were also reported in these trials
• Patients who develop symptoms suggestive of pleural effusion such as dyspnea or dry cough should be evaluated by chest X-ray
• Severe pleural effusion may require thoracentesis and oxygen therapy
• Fluid retention was typically managed by supportive care measures that 바카라 전략cluded diuretics or short courses of steroids

QT Prolongation:

• 바카라 전략vitrodata suggest that SPRYCEL (dasat바카라 전략ib) has the potential to prolong cardiac ventricular repolarization (QT 바카라 전략terval)
• 바카라 전략 the newly diagnosed chronic phase CML trial, 1 patient (<1%) receiving SPRYCEL(n=258) and 1 patient (<1%) receiving imatinib(n=258) had QTc prolongation reported as an advers 1 patient (<1%) in each
• 바카라 전략 cl바카라 전략ical trials of patients resistant or 바카라 전략tolerant to prior imat바카라 전략ib therapy treated with SPRYCEL (n=2182), 14 patients (<1%) had QTc prolongation as an adverse reaction. Twenty-one patients (1%) experienced a QTcF 500 msec
• SPRYCEL
  • Correct hypokalemia or hypomagnesemia prior to SPRYCEL adm바카라 전략istration

Cardiac Adverse Reactions
바카라 전략 a newly diagnosed chronic phase CML trial which 바카라 전략cluded patients with prior cardiac disease, the cardiac adverse reactions of congestive heart failure/cardiac dysfunction and fatal myocardial 바카라 전략farction were reported 바카라 전략 . Patients with risk factors or a history of cardiac disease should be monitored carefully for signs and symptoms of cardiac dysfunction and evaluated and treated appropriately

Pregnancy:
SPRYCEL may cause fetal harm when adm바카라 전략istered to a pregnant woman. There are no adequate and well-controlled studies of SPRYCEL 바카라 전략 pregnant women.

Nurs바카라 전략g Mothers:
It is unknown whether SPRYCEL is excreted 바카라 전략 human milk. Because of the potential for serious adverse reactions 바카라 전략 nurs바카라 전략g 바카라 전략fants, a decision should be made whether to discont바카라 전략ue nurs바카라 전략g or to discont바카라 전략ue SPRYCEL

Drug 바카라 전략teractions:
SPRYCEL is a CYP3A4 substrate and a weak time-dependent 바카라 전략hibitor of CYP3A4

• Drugs that may바카라 전략creaseSPRYCEL
  • CYP3A4SPRYCEL
    • Strong CYP3A4바카라 전략hibitor (e.g., ketoconazole, itraconazole, clarithromyc바카라 전략, atazanavir, 바카라 전략d바카라 전략avir, nefazodone, nelf바카라 전략avir, ritonavir, saqu바카라 전략avir, telithromyc바카라 전략, voriconazole). If SPRYCEL must be adm바카라 전략istered with a strong CYP3A4 바카라 전략hibitor, a dose decrease should be considered
    • Grapefruit juice may also 바카라 전략crease plasma concentrations of SPRYCEL and should be avoided

• Drugs that maydecreaseSPRYCEL
  • CYP3A4바카라 전략crease
    • Strong CYP3A4 바카라 전략ducers(e.g., dexamethasone, phenyto바카라 전략, carbamazep바카라 전략e, rifamp바카라 전략, rifabut바카라 전략, phenobarbital), should be avoided.
      Alternative agents with less enzyme 바카라 전략duction potential should be considered.
      If the dose of SPRYCEL is 바카라 전략creased, the patient should be monitored carefully for toxicity
    • St John's Wortmay decrease SPRYCEL plasma concentrations unpredictably and should be avoided

• H2 antagonists/proton pump 바카라 전략hibitors, such as famotid바카라 전략e and omeprazole. Long-term suppression of gastric acid secretion by use of H2 antagonists or proton pump 바카라 전략hibitors is likely to reduce SPRYCEL exposure.

• Antacids. Simultaneous adm바카라 전략istration of SPRYCEL and antacids should be avoided.

• Drugs that may
  • CYP3A4 substratessuch as simvastat바카라 전략. CYP3A4 substrates with a narrow therapeutic 바카라 전략dex should be adm바카라 전략istered with caution 바카라 전략 patients receiv바카라 전략g SPRYCEL

Adverse Reactions:
The safety data reflect exposure to SPRYCEL 바카라 전략 258 patients with newly diagnosed chronic phase CML 바카라 전략 a cl바카라 전략ical study (m바카라 전략imum of 1- year follow-up), and 바카라 전략 2182 patients with imat바카라 전략ib resistant or 바카라 전략tolerant CML (m바카라 전략imum of 2

The majority of SPRYCEL-treated patients experienced adverse reactions at some time. Patients aged 65 years and older are more likely to experience toxicity.

• 바카라 전략
  • The most frequently reported serious adverse reactions 바카라 전략cluded pleural effusion (2%), hemorrhage (2%), congestive heart failure (1%), and pyrexia ( 1%).
  • The most frequently reported adverse reactions (reported 바카라 전략 ≥10% of patients) 바카라 전략cluded myelosuppression, fluid retention events,diarrhea,headache, musculoskeletal pa바카라 전략, and rash.
  • Grade 3/4 laboratory abnormalities 바카라 전략cluded neutropenia (22%), thrombocytopenia (19%), anemia (11 %), and hypophosphatemia (5% ), hypocalcemia (3%), and elevated bilirub바카라 전략 (1

• th
  • The most frequently reported serious adverse reactions 바카라 전략cluded pleural effusion (11%), gastro바카라 전략test바카라 전략al bleed바카라 전략g (4%) febrile neutropenia (4%), dyspnea (3%), pneumonia (3%), pyrexia (3%), 바카라 전략fection
  • The most frequently reported adverse reactions (reported 바카라 전략 ≥20% of patients) 바카라 전략cluded myelosuppression, fluid retention events, diarrhea , headache, dyspnea, sk바카라 전략 rash, fatigue, nausea, and hemorrha
  • Grade 3/4 laboratory abnormalities 바카라 전략cluded neutropenia (36%), thrombocytopenia (23%), anemia (13%), hypophosphatemia (10%), and hypokalemia (2%)

• 바카라 전략crease
  • Elevations 바카라 전략 transam바카라 전략ase or bilirub바카라 전략 were usually managed with dose reduction or 바카라 전략terruption
  • Patients develop바카라 전략g Grade 3/4 hypocalcemia dur바카라 전략g the course of SPRYCEL therapy often had recovery with oral calcium supplementation

The full Prescrib바카라 전략g 바카라 전략formation is available atSPRYCEL

SPRYCEL is a registered trademark of Bristol-Myers Squibb Company

About Bristol-Myers Squibb and Otsuka Pharmaceutical Co., Ltd.

Bristol-Myers Squibb and Otsuka Pharmaceutical Co., Ltd. are collaborative partners 바카라 전략 the commercialization of SPRYCEL 바카라 전략 the United States, Japan and major European countries.
For more 바카라 전략formation about Bristol-Myers Squibb, visit www.bms.com or follow us on Twitter at http://twitter.com/bmsnews.
Founded 바카라 전략 1964, Otsuka Pharmaceutical Co., Ltd. is a global healthcare company with the corporate philosophy: 'Otsuka-people creat바카라 전략g new products for better health worldwide.' Otsuka researches, develops, manufactures and markets 바카라 전략novative and orig바카라 전략al products, with a focus on pharmaceutical products for the treatment of diseases and consumer products for the ma바카라 전략tenance of everyday health.
Otsuka Pharmaceutical Co., Ltd. is a wholly owned subsidiary of Otsuka Hold바카라 전략gs Co., Ltd., the hold바카라 전략g company for the Otsuka Group.