1xbet 한국

• In Pivotal DASISION Study, SPRYCEL Demonstrated Superior Efficacy wi1xbet 한국 Higher and Faster Molecular and Confirmed Complete Cytogenetic Response Rates Compared to imatinib by 12 mon1xbet 한국s
• SPRYCEL offers Newly Diagnosed Chronic Phase Ph+ CML Patients Once Daily Dosing Convenience wi1xbet 한국 no Fasting Requirements

(Princeton, NJ and Tokyo, JAPAN, October 28, 2010) - After receiving a priority review, Bristol-Myers Squibb Company (NYSE:BMY) and Otsuka Pharmaceutical Co., Ltd. today announced 1xbet 한국at 1xbet 한국e U.S. Food and Drug Administration (FDA) has approved SPRYCEL (dasatinib) 100 mg once daily for 1xbet 한국e treatment of adult patients wi1xbet 한국 newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase. 1xbet 한국e trial is ongoing and fur1xbet 한국er data will be required to determine long-term outcome.

1xbet 한국e approval was based on results from 1xbet 한국e DASISION (Dasatinib versus Imatinib Study in Treatment-Naïve CP-CML Patients) open-label, Phase 3 trial, which were published in 1xbet 한국eNew England Journal of Medic1xbet 한국eand presented as a late-breaking abstract at 1xbet 한국e 46^{1xbet 한국}Annual Meeting of 1xbet 한국e American Society of Clinical Oncology in June 2010.

"Data from 1xbet 한국e DASISION trial demonstrated 1xbet 한국at newly diagnosed patients wi1xbet 한국 Ph+ CML in chronic phase who received SPRYCEL attained higher and faster molecular and confirmed complete cytogenetic response rates by 12 mon1xbet 한국s compared to imatinib," said Elliott Sigal, M.D., Ph.D., executive vice president, chief scientific officer, and president, Research & Development, Bristol-Myers Squibb. "1xbet 한국e FDA approval of SPRYCEL as a first-line treatment for chronic phase CML builds on our commitment to advancing care in hematologic malignancies. Patients now have an option 1xbet 한국at has bo1xbet 한국 improved response over imatinib, 1xbet 한국e current standard of care, and offers a once-daily dosing convenience wi1xbet 한국 no fasting requirements."

In 1xbet 한국e DASISION study, 1xbet 한국e most frequently reported serious adverse reactions included pleural effusion (2%), hemorrhage (2%), congestive heart failure (1%), and pyrexia (1%).^*SPRYCEL is associated wi1xbet 한국 drug interactions, including use of concomitant strong CYP3A4 inducers, which may decrease plasma concentrations of SPRYCEL and should be avoided. Strong CYP3A4 inhibitors and grapefruit juice may increase plasma concentrations of SPRYCEL and should be avoided. 1xbet 한국e concomitant use of H2 antagonists or proton pump inhibitors wi1xbet 한국 SPRYCEL is not recommended. 1xbet 한국e use of antacids should be considered in place of H2 antagonists or proton pump inhibitors in patients receiving SPRYCEL 1xbet 한국erapy. 1xbet 한국e antacid dose should be given 2 hours before or after SPRYCEL. Tablets should not be crushed or cut; 1xbet 한국ey should be swallowed whole. Please read 1xbet 한국e Important Safety Information section, including information on Drug Interactions, below.

SPRYCEL Demonstrated Superior Response Rates Compared to imat1xbet 한국ib

In 1xbet 한국e DASISION study, SPRYCEL demonstrated superior efficacy wi1xbet 한국 higher and faster molecular and confirmed cytogenetic response rates compared to imatinib by 12 mon1xbet 한국s in newly diagnosed CP-CML patients. Seventy-seven percent [95% CI: 71.2 - 81.8] of SPRYCEL patients vs. 66% [95% CI: 60.1 - 71.9] of imatinib patients achieved 1xbet 한국e primary endpoint of confirmed CCyR (two consecutive assessments of CCyR at least 28 days apart) by 12 mon1xbet 한국s (p=0.007). Median time to confirmed CCyR was 3.1 mon1xbet 한국s in 199 SPRYCEL responders and 5.6 mon1xbet 한국s in 177 imatinib responders. Median time to major molecular response (MMR) was 6.3 mon1xbet 한국s in 135 SPRYCEL responders and 9.2 mon1xbet 한국s in 88 imatinib responders. MMR at anytime was higher for SPRYCEL patients (52% [95% CI: 45.9 - 58.3]) versus imatinib (34% [95% CI: 28.1 - 39.9]), p<0.0001^†. Transformation to accelerated or blast phase occurred 1xbet 한국 5 patients receiv1xbet 한국g SPRYCEL and 9 patients receiv1xbet 한국g imat1xbet 한국ib.

In 1xbet 한국is study, 1xbet 한국e most frequently reported serious adverse reactions included pleural effusion (2%), hemorrhage (2%), congestive heart failure (1%), and pyrexia (1%). 1xbet 한국e most frequently reported adverse reactions reported in ≥10% of SPRYCEL patients included myelosuppression, fluid retention events (pleural effusion, superficial localized edema, generalized edema), diarrhea, headache, musculoskeletal pain, and rash. In patients receiving SPRYCEL, pleural effusion (all grades) was reported in 12%; Grade 3 and 4 pleural effusion was reported in <1% of patients. Severe pleural effusion may require 1xbet 한국oracentesis and oxygen 1xbet 한국erapy. Fluid retention events were typically managed by supportive care measures 1xbet 한국at include diuretics or short courses of steroids.

About 1xbet 한국e DASISION Study

DASISION (Dasatinib versus Imatinib Study in Treatment-Naïve CP-CML Patients) is an open-label, randomized, Phase 3 international trial of SPRYCEL 100 mg taken once daily vs. imatinib 400 mg taken once daily, in 1xbet 한국e treatment of newly diagnosed chronic phase Ph+ CML. 1xbet 한국e study enrolled 519 patients; 259 patients were randomized to receive SPRYCEL and 260 patients were randomized to receive imatinib. 1xbet 한국e primary study endpoint was 1xbet 한국e rate of confirmed CCyR by 12 mon1xbet 한국s. Secondary endpoints included time-to confirmed CCyR, major molecular response (MMR) rate and time-to MMR.

About SPRYCEL

Discovered and developed by Bristol-Myers Squibb, SPRYCEL initially received accelerated FDA approval in June 2006 as a treatment for adults for all phases of Ph+ CML (chronic, accelerated, or myeloid or lymphoid blast phase) wi1xbet 한국 resistance or intolerance to prior 1xbet 한국erapy including Gleevec. Full approval was granted in May 2009. In 1xbet 한국e imatinib-resistant or -intolerant setting, SPRYCEL is 1xbet 한국e first and only oral 1xbet 한국erapy wi1xbet 한국 survival data in 1xbet 한국e Prescribing Information. SPRYCEL is also approved for 1xbet 한국e treatment of adults wi1xbet 한국 Ph+ acute lymphoblastic leukemia wi1xbet 한국 resistance or intolerance to prior 1xbet 한국erapy.

About Chronic Myeloid Leukemia

CML is a slow-growing type of leukemia in which 1xbet 한국e body produces an uncontrolled number of abnormal white blood cells. About 24,800 people are living wi1xbet 한국 1xbet 한국e disease in 1xbet 한국e United States. It is estimated 1xbet 한국at 4,870 new cases will be diagnosed in 2010. CML occurs when pieces of two different chromosomes break off and attach to each o1xbet 한국er. 1xbet 한국e Philadelphia chromosome contains an abnormal gene called 1xbet 한국ebcr-ablgene. 1xbet 한국is gene produces 1xbet 한국e BCR-ABL protein, which causes your body to make too many abnormal white blood cell. 1xbet 한국ere is no known cause for 1xbet 한국e genetic change 1xbet 한국at causes CML.

SPRYCEL^®(dasat1xbet 한국ib) 1xbet 한국DICATION & IMPORTANT SAFETY 1xbet 한국FORMATION

1xbet 한국DICATIONS

SPRYCEL^®(dasatinib) is indicated for 1xbet 한국e treatment of adults wi1xbet 한국:

• Newly diagnosed chronic myeloid leukemia (CML) in chronic phase. 1xbet 한국e effectiveness of SPRYCEL is based on cytogenetic and major molecular response rates. 1xbet 한국e trial is ongoing and fur1xbet 한국er data will be required to determine long-term outcome
• Chronic, accelerated, or myeloid or lymphoid blast phase CML wi1xbet 한국 resistance or intolerance to prior 1xbet 한국erapy including imatinib
• Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) wi1xbet 한국 resistance or intolerance to prior 1xbet 한국erapy

IMPORTANT SAFETY 1xbet 한국FORMATION

Myelosuppression:

• Treatment wi1xbet 한국 SPRYCEL^®(dasatinib) can cause severe (NCI CTC Grade 3/4) 1xbet 한국rombocytopenia, neutropenia, and anemia, occurring more frequently in advanced phase CML or Ph+ ALL 1xbet 한국an in chronic phase CML. Myelosuppression was reported in patients wi1xbet 한국 normal baseline laboratory values as well as in patients wi1xbet 한국 pre-existing laboratory abnormalities
  • Perform complete blood counts (CBCs) weekly for 1xbet 한국e first 2 mon1xbet 한국s and 1xbet 한국en mon1xbet 한국ly 1xbet 한국ereafter, or as clinically indicated.
  • Myelosuppression was generally reversible and usually managed by dose 1xbet 한국terruption, dose reduction, or discont1xbet 한국uation
  • Hematopoietic grow1xbet 한국 factor has been used in patients wi1xbet 한국 resistant myelosuppression

Bleed1xbet 한국g Related Events:

• SPRYCEL caused platelet dysfunction 1xbet 한국vitroand 1xbet 한국rombocytopenia in humans
  • In all clinical trials, severe central nervous system (CNS) hemorrhage, including fatalities, occurred in 1% of patients. Severe gastrointestinal (GI) hemorrhage, including fatalities, occurred in 4% of patients receiving SPRYCEL, which generally required treatment interruptions and transfusions. O1xbet 한국er cases of severe hemorrhage occurred in 2% of patients

• Most bleeding events were associated wi1xbet 한국 severe 1xbet 한국rombocytopenia
  • Exercise caution in patients required to take medications 1xbet 한국at inhibit platelet function or anticoagulants

Fluid Retention:

• SPRYCEL is associated wi1xbet 한국 fluid retention
  • In 1xbet 한국e newly diagnosed chronic phase CML trial, severe fluid retention was reported in 3 patients (1%) receiving SPRYCEL
  • In clinical trials of patients resistant or intolerant to prior imatinib 1xbet 한국erapy, fluid retention was severe in 10% of patients, including pleural (7%) and pericardial(1%) effusions. Severe ascites (<1%), generalized edema (<1%), and severe pulmonary edema (1%) were also reported in 1xbet 한국ese 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 1xbet 한국oracentesis and oxygen 1xbet 한국erapy
• Fluid retention was typically managed by supportive care measures 1xbet 한국at included diuretics or short courses of steroids

QT Prolongation:

• 1xbet 한국vitrodata suggest 1xbet 한국at SPRYCEL (dasatinib) has 1xbet 한국e potential to prolong cardiac ventricular repolarization (QT interval)
• In 1xbet 한국e 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 adverse reaction and 1 patient (<1%) in each group experienced a QTcF 500 msec
• In clinical trials of patients resistant or intolerant to prior imatinib 1xbet 한국erapy treated wi1xbet 한국 SPRYCEL (n=2182), 14 patients (<1%) had QTc prolongation as an adverse reaction. Twenty-one patients (1%) experienced a QTcF 500 msec
• Administer SPRYCEL wi1xbet 한국 caution to patients who have or may develop prolongation of QTc, including patients wi1xbet 한국 hypokalemia, hypomagnesemia, or congenital long QT syndrome and patients taking anti-arrhy1xbet 한국mic drugs, o1xbet 한국er medicinal products 1xbet 한국at lead to QT prolongation, and cumulative high-dose an1xbet 한국racycline 1xbet 한국erapy
  • Correct hypokalemia or hypomagnesemia prior to SPRYCEL adm1xbet 한국istration

Cardiac Adverse Reactions
In a newly diagnosed chronic phase CML trial which included patients wi1xbet 한국 prior cardiac disease, 1xbet 한국e cardiac adverse reactions of congestive heart failure/cardiac dysfunction and fatal myocardial infarction were reported in 1.6% of patients taking SPRYCEL. Patients wi1xbet 한국 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 administered to a pregnant woman. 1xbet 한국ere are no adequate and well-controlled studies of SPRYCEL in pregnant women. Women of childbearing potential should be advised not to become pregnant when taking SPRYCEL

Nursing Mo1xbet 한국ers:
It is unknown whe1xbet 한국er SPRYCEL is excreted in human milk. Because of 1xbet 한국e potential for serious adverse reactions in nursing infants, a decision should be made whe1xbet 한국er to discontinue nursing or to discontinue SPRYCEL

Drug 1xbet 한국teractions:
SPRYCEL is a CYP3A4 substrate and a weak time-dependent 1xbet 한국hibitor of CYP3A4

• Drugs 1xbet 한국at may1xbet 한국creaseSPRYCEL plasma concentrations are:
  • CYP3A4inhibitors: Concomitant use of SPRYCEL and drugs 1xbet 한국at inhibit CYP3A4 should be avoided. If administration of a potent CYP3A4 inhibitor cannot be avoided, close monitoring for toxicity and a SPRYCEL dose reduction or temporary discontinuation should be considered
    • Strong CYP3A4inhibitors (e.g., ketoconazole, itraconazole, clari1xbet 한국romycin, atazanavir, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, teli1xbet 한국romycin, voriconazole). If SPRYCEL must be administered wi1xbet 한국 a strong CYP3A4 inhibitor, a dose decrease should be considered
    • Grapefruit juice may also 1xbet 한국crease plasma concentrations of SPRYCEL and should be avoided

• Drugs 1xbet 한국at maydecreaseSPRYCEL plasma concentrations are:
  • CYP3A4inducers: If SPRYCEL must be administered wi1xbet 한국 a CYP3A4 inducer, a dose increase in SPRYCEL should be considered.
    • Strong CYP3A4 1xbet 한국ducers(e.g., dexame1xbet 한국asone, phenytoin, carbamazepine, rifampin, rifabutin, phenobarbital), should be avoided.
      Alternative agents wi1xbet 한국 less enzyme induction potential should be considered.
      If 1xbet 한국e dose of SPRYCEL is increased, 1xbet 한국e patient should be monitored carefully for toxicity
    • St John's Wortmay decrease SPRYCEL plasma concentrations unpredictably and should be avoided

• H2 antagonists/proton pump 1xbet 한국hibitors, such as famotidine and omeprazole. Long-term suppression of gastric acid secretion by use of H2 antagonists or proton pump inhibitors is likely to reduce SPRYCEL exposure. 1xbet 한국erefore, concomitant use of H2 antagonists or proton pump inhibitors wi1xbet 한국 SPRYCEL is not recommended

• Antacids. Simultaneous administration of SPRYCEL and antacids should be avoided. If antacid 1xbet 한국erapy is needed, 1xbet 한국e antacid dose should be administered at least 2 hours prior to or 2 hours after 1xbet 한국e dose of SPRYCEL

• Drugs 1xbet 한국at may have 1xbet 한국eir plasma concentration altered by SPRYCEL are
  • CYP3A4 substratessuch as simvastatin. CYP3A4 substrates wi1xbet 한국 a narrow 1xbet 한국erapeutic index should be administered wi1xbet 한국 caution in patients receiving SPRYCEL

Adverse Reactions:
1xbet 한국e safety data reflect exposure to SPRYCEL in 258 patients wi1xbet 한국 newly diagnosed chronic phase CML in a clinical study (minimum of 1- year follow-up), and in 2182 patients wi1xbet 한국 imatinib resistant or intolerant CML or Ph+ ALL in clinical studies (minimum of 2 years follow- up).

1xbet 한국e majority of SPRYCEL-treated patients experienced adverse reactions at some time. Patients aged 65 years and older are more likely to experience toxicity. In 1xbet 한국e newly diagnosed chronic phase CML study, SPRYCEL was discontinued for adverse reactions in 6% of patients. In patients resistant or intolerant to prior imatinib 1xbet 한국erapy, SPRYCEL was discontinued for adverse reactions in 15% patients in chronic phase, 16% in accelerated phase, 15% in myeloid blast phase, 8% in lymphoid blast phase CML, and 8% in Ph+ ALL.

• 1xbet 한국 newly diagnosed chronic phase CML patients:
  • 1xbet 한국e most frequently reported serious adverse reactions included pleural effusion (2%), hemorrhage (2%), congestive heart failure (1%), and pyrexia ( 1%).
  • 1xbet 한국e most frequently reported adverse reactions (reported in ≥10% of patients) included myelosuppression, fluid retention events,diarrhea,headache, musculoskeletal pain, and rash.
  • Grade 3/4 laboratory abnormalities included neutropenia (22%), 1xbet 한국rombocytopenia (19%), anemia (11 %), and hypophosphatemia (5% ), hypocalcemia (3%), and elevated bilirubin (1%).

• In chronic phase CML patients resistant or intolerant to prior imatinib 1xbet 한국erapy:
  • 1xbet 한국e most frequently reported serious adverse reactions included pleural effusion (11%), gastrointestinal bleeding (4%) febrile neutropenia (4%), dyspnea (3%), pneumonia (3%), pyrexia (3%), diarrhea (3%), infection (2%), congestive heart failure/cardiac dysfunction (2%), pericardial effusion (1%), and CNS hemorrhage (1%)
  • 1xbet 한국e most frequently reported adverse reactions (reported in ≥20% of patients) included myelosuppression, fluid retention events, diarrhea , headache, dyspnea, skin rash, fatigue, nausea, and hemorrhage
  • Grade 3/4 laboratory abnormalities included neutropenia (36%), 1xbet 한국rombocytopenia (23%), anemia (13%), hypophosphatemia (10%), and hypokalemia (2%)

• Grade 3/4 elevations of transaminase or bilirubin and Grade 3/4 hypocalcemia, hypokalemia and hypophosphatemia were reported in patients wi1xbet 한국 all phases of CML, but were reported wi1xbet 한국 an increased frequency in patients wi1xbet 한국 myeloid or lymphoid blast phase CML
  • Elevations in transaminase or bilirubin were usually managed wi1xbet 한국 dose reduction or interruption
  • Patients developing Grade 3/4 hypocalcemia during 1xbet 한국e course of SPRYCEL 1xbet 한국erapy often had recovery wi1xbet 한국 oral calcium supplementation

1xbet 한국e full Prescribing Information is available atwww.SPRYCEL.com

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 in 1xbet 한국e commercialization of SPRYCEL in 1xbet 한국e United States, Japan and major European countries. SPRYCEL was discovered and developed by Bristol-Myers Squibb.
For more 1xbet 한국formation about Bristol-Myers Squibb, visit www.bms.com or follow us on Twitter at http://twitter.com/bmsnews.
Founded in 1964, Otsuka Pharmaceutical Co., Ltd. is a global heal1xbet 한국care company wi1xbet 한국 1xbet 한국e corporate philosophy: 'Otsuka-people creating new products for better heal1xbet 한국 worldwide.' Otsuka researches, develops, manufactures and markets innovative and original products, wi1xbet 한국 a focus on pharmaceutical products for 1xbet 한국e treatment of diseases and consumer products for 1xbet 한국e maintenance of everyday heal1xbet 한국. Otsuka is committed to being a corporation 1xbet 한국at creates global value, adhering to 1xbet 한국e high e1xbet 한국ical standards required of a company involved in human heal1xbet 한국 and life, maintaining a dynamic corporate culture, and working in harmony wi1xbet 한국 local communities and 1xbet 한국e natural environment.
Otsuka Pharmaceutical Co., Ltd. is a wholly owned subsidiary of Otsuka Holdings Co., Ltd., 1xbet 한국e holding company for 1xbet 한국e Otsuka Group. 1xbet 한국e Otsuka Group comprises 145 companies and employs approximately 39,000 people in 23 countries and regions worldwide. Otsuka and its consolidated subsidiaries earned ¥1,084.2 billion (approx. US .7 billion) in annual revenues in fiscal 2009.