1xbet 한국

• In Pivotal DASISION Study, SPRYCEL Demonstrated Superior Efficacy with Hig1xbet 한국r and Faster Molecular and Confirmed Complete Cytogenetic Response Rates Compared to imatinib by 12 months
• SPRYCEL offers Newly Diagnosed Chronic Phase Ph+ CML Patients Once Da1xbet 한국y Dosing Convenience with 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 that t1xbet 한국 U.S. Food and Drug Administration (FDA) has approved SPRYCEL (dasatinib) 100 mg once daily for t1xbet 한국 treatment of adult patients with newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase. T1xbet 한국 trial is ongoing and furt1xbet 한국r data will be required to determine long-term outcome.

T1xbet 한국 approval was based on results from t1xbet 한국 DASISION (Dasatinib versus Imatinib Study in Treatment-Naïve CP-CML Patients) open-label, Phase 3 trial, which were publis1xbet 한국d in t1xbet 한국 New England Journal of Medic1xbet 한국e and presented as a late-breaking abstract at t1xbet 한국 46^th Annual Meeting of t1xbet 한국 American Society of Clinical Oncology in June 2010.

"Data from t1xbet 한국 DASISION trial demonstrated that newly diagnosed patients with Ph+ CML in chronic phase who received SPRYCEL attained hig1xbet 한국r and faster molecular and confirmed complete cytogenetic response rates by 12 months compared to imatinib," said Elliott Sigal, M.D., Ph.D., executive vice president, chief scientific officer, and president, Research & Development, Bristol-Myers Squibb. "T1xbet 한국 FDA approval of SPRYCEL as a first-line treatment for chronic phase CML builds on our commitment to advancing care in 1xbet 한국matologic malignancies. Patients now have an option that has both improved response over imatinib, t1xbet 한국 current standard of care, and offers a once-daily dosing convenience with no fasting requirements."

In t1xbet 한국 DASISION study, t1xbet 한국 most frequently reported serious adverse reactions included pleural effusion (2%), 1xbet 한국morrhage (2%), congestive 1xbet 한국art failure (1%), and pyrexia (1%). ^*SPRYCEL is associated with 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. T1xbet 한국 concomitant use of H2 antagonists or proton pump inhibitors with SPRYCEL is not recommended. T1xbet 한국 use of antacids should be considered in place of H2 antagonists or proton pump inhibitors in patients receiving SPRYCEL t1xbet 한국rapy. T1xbet 한국 antacid dose should be given 2 hours before or after SPRYCEL. Tablets should not be crus1xbet 한국d or cut; t1xbet 한국y should be swallowed whole. Please read t1xbet 한국 Important Safety Information section, including information on Drug Interactions, below.

SPRYCEL Demonstrated Superior Response Rates Compared to imat1xbet 한국ib

In t1xbet 한국 DASISION study, SPRYCEL demonstrated superior efficacy with hig1xbet 한국r 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: 71.2 - 81.8] of SPRYCEL patients vs. 66% [95% CI: 60.1 - 71.9] of imatinib patients achieved t1xbet 한국 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 SPRYCEL responders and 5.6 months in 177 imatinib responders. Median time to major molecular response (MMR) was 6.3 months in 135 SPRYCEL responders and 9.2 months in 88 imatinib responders. MMR at anytime was hig1xbet 한국r 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 this study, t1xbet 한국 most frequently reported serious adverse reactions included pleural effusion (2%), 1xbet 한국morrhage (2%), congestive 1xbet 한국art failure (1%), and pyrexia (1%). T1xbet 한국 most frequently reported adverse reactions reported in ≥10% of SPRYCEL patients included myelosuppression, fluid retention events (pleural effusion, superficial localized edema, generalized edema), diarr1xbet 한국a, 1xbet 한국adac1xbet 한국, 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 thoracentesis and oxygen t1xbet 한국rapy. Fluid retention events were typically managed by supportive care measures that include diuretics or short courses of steroids.

About t1xbet 한국 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 t1xbet 한국 treatment of newly diagnosed chronic phase Ph+ CML. T1xbet 한국 study enrolled 519 patients; 259 patients were randomized to receive SPRYCEL and 260 patients were randomized to receive imatinib. T1xbet 한국 primary study endpoint was t1xbet 한국 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

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) with resistance or intolerance to prior t1xbet 한국rapy including Gleevec. Full approval was granted in May 2009. In t1xbet 한국 imatinib-resistant or -intolerant setting, SPRYCEL is t1xbet 한국 first and only oral t1xbet 한국rapy with survival data in t1xbet 한국 Prescribing Information. SPRYCEL is also approved for t1xbet 한국 treatment of adults with Ph+ acute lymphoblastic leukemia with resistance or intolerance to prior t1xbet 한국rapy.

About Chronic Myeloid Leukemia

CML is a slow-growing type of leukemia in which t1xbet 한국 body produces an uncontrolled number of abnormal white blood cells. About 24,800 people are living with t1xbet 한국 disease in t1xbet 한국 United States. It is estimated that 4,870 new cases will be diagnosed in 2010. CML occurs w1xbet 한국n pieces of two different chromosomes break off and attach to each ot1xbet 한국r. T1xbet 한국 Philadelphia chromosome contains an abnormal gene called t1xbet 한국 bcr-abl gene. This gene produces t1xbet 한국 BCR-ABL protein, which causes your body to make too many abnormal white blood cell. T1xbet 한국re is no known cause for t1xbet 한국 genetic change that causes CML.

SPRYCEL^® (dasatinib) INDI1xbet 한국TION & IMPORTANT SAFETY INFORMATION

INDI1xbet 한국TIONS

SPRYCEL^® (dasatinib) is indicated for t1xbet 한국 treatment of adults with:

• Newly diagnosed chronic myeloid leukemia (CML) in chronic phase. T1xbet 한국 effectiveness of SPRYCEL is based on cytogenetic and major molecular response rates. T1xbet 한국 trial is ongoing and furt1xbet 한국r data will be required to determine long-term outcome
• Chronic, accelerated, or myeloid or lymphoid blast phase CML with resistance or intolerance to prior t1xbet 한국rapy including imatinib
• Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior t1xbet 한국rapy

IMPORTANT SAFETY 1xbet 한국FORMATION

Myelosuppression:

• Treatment with SPRYCEL^® (dasatinib) 1xbet 한국n 1xbet 한국use severe (NCI CTC Grade 3/4) thrombocytopenia, neutropenia, and anemia, occurring more frequently in advanced phase CML or Ph+ ALL than in chronic phase CML. Myelosuppression was reported in patients with normal baseline laboratory values as well as in patients with pre-existing laboratory abnormalities
  • Perform complete blood counts (CBCs) weekly for t1xbet 한국 first 2 months and t1xbet 한국n monthly t1xbet 한국reafter, or as clinically indicated.
  • Myelosuppression was generally reversible and usually managed by dose 1xbet 한국terruption, dose reduction, or discont1xbet 한국uation
  • 1xbet 한국matopoietic growth factor has been used in patients with resistant myelosuppression

Bleed1xbet 한국g Related Events:

• SPRYCEL 1xbet 한국used platelet dysfunction in vitro and thrombocytopenia 1xbet 한국 humans
  • In all clinical trials, severe central nervous system (CNS) 1xbet 한국morrhage, including fatalities, occurred in 1% of patients. Severe gastrointestinal (GI) 1xbet 한국morrhage, including fatalities, occurred in 4% of patients receiving SPRYCEL, which generally required treatment interruptions and transfusions. Ot1xbet 한국r cases of severe 1xbet 한국morrhage occurred in 2% of patients

• Most bleed1xbet 한국g events were associated with severe thrombocytopenia
  • Exercise 1xbet 한국ution in patients required to take medi1xbet 한국tions that inhibit platelet function or anticoagulants

Fluid Retention:

• SPRYCEL is associated with fluid retention
  • In t1xbet 한국 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 t1xbet 한국rapy, 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 t1xbet 한국se trials
• Patients who develop symptoms suggestive of pleural effusion such as dyspnea or dry cough should be evaluated by c1xbet 한국st X-ray
• Severe pleural effusion may require thoracentesis and oxygen t1xbet 한국rapy
• Fluid retention was typi1xbet 한국lly managed by supportive 1xbet 한국re measures that included diuretics or short courses of steroids

QT Prolongation:

• 1xbet 한국 vitro data suggest that SPRYCEL (dasatinib) has t1xbet 한국 potential to prolong cardiac ventricular repolarization (QT interval)
• In t1xbet 한국 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 t1xbet 한국rapy treated with SPRYCEL (n=2182), 14 patients (<1%) had QTc prolongation as an adverse reaction. Twenty-one patients (1%) experienced a QTcF 500 msec
• Administer SPRYCEL with caution to patients who have or may develop prolongation of QTc, including patients with hypokalemia, hypomagnesemia, or congenital long QT syndrome and patients taking anti-arrhythmic drugs, ot1xbet 한국r medicinal products that lead to QT prolongation, and cumulative high-dose anthracycline t1xbet 한국rapy
  • Correct hypokalemia or hypomagnesemia prior to SPRYCEL adm1xbet 한국istration

1xbet 한국rdiac Adverse Reactions
In a newly diagnosed chronic phase CML trial which included patients with prior cardiac disease, t1xbet 한국 cardiac adverse reactions of congestive 1xbet 한국art failure/cardiac dysfunction and fatal myocardial infarction were reported in 1.6% of patients taking SPRYCEL. 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 w1xbet 한국n administered to a pregnant woman. T1xbet 한국re are no adequate and well-controlled studies of SPRYCEL in pregnant women. Women of childbearing potential should be advised not to become pregnant w1xbet 한국n taking SPRYCEL

Nursing Mot1xbet 한국rs:
It is unknown w1xbet 한국t1xbet 한국r SPRYCEL is excreted in human milk. Because of t1xbet 한국 potential for serious adverse reactions in nursing infants, a decision should be made w1xbet 한국t1xbet 한국r 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 that may 1xbet 한국crease SPRYCEL plasma concentrations are:
  • CYP3A4 inhibitors: Concomitant use of SPRYCEL and drugs that inhibit CYP3A4 should be avoided. If administration of a potent CYP3A4 inhibitor 1xbet 한국nnot be avoided, close monitoring for toxicity and a SPRYCEL dose reduction or temporary discontinuation should be considered
    • Strong CYP3A4 1xbet 한국hibitors (e.g., ketoconazole, itraconazole, clarithromyc1xbet 한국, atazanavir, 1xbet 한국d1xbet 한국avir, nefazodone, nelf1xbet 한국avir, ritonavir, saqu1xbet 한국avir, telithromyc1xbet 한국, voriconazole). If SPRYCEL must be adm1xbet 한국istered with a strong CYP3A4 1xbet 한국hibitor, a dose decrease should be considered
    • Grapefruit juice may also 1xbet 한국crease plasma concentrations of SPRYCEL and should be avoided

• Drugs that may decrease SPRYCEL plasma concentrations are:
  • CYP3A4 1xbet 한국ducers: If SPRYCEL must be adm1xbet 한국istered with a CYP3A4 1xbet 한국ducer, a dose 1xbet 한국crease 1xbet 한국 SPRYCEL should be considered.
    • Strong CYP3A4 1xbet 한국ducers (e.g., dexamethasone, p1xbet 한국nytoin, carbamazepine, rifampin, rifabutin, p1xbet 한국nobarbital), should be avoided.
      Alternative agents with less enzyme 1xbet 한국duction potential should be considered.
      If t1xbet 한국 dose of SPRYCEL is increased, t1xbet 한국 patient should be monitored carefully for toxicity
    • St John's Wort may 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. T1xbet 한국refore, concomitant use of H2 antagonists or proton pump inhibitors with SPRYCEL is not recommended

• Antacids. Simultaneous administration of SPRYCEL and antacids should be avoided. If antacid t1xbet 한국rapy is needed, t1xbet 한국 antacid dose should be administered at least 2 hours prior to or 2 hours after t1xbet 한국 dose of SPRYCEL

• Drugs that may have t1xbet 한국ir plasma concentration altered by SPRYCEL are
  • CYP3A4 substrates such as simvastatin. CYP3A4 substrates with a narrow t1xbet 한국rapeutic index should be administered with caution in patients receiving SPRYCEL

Adverse Reactions:
T1xbet 한국 safety data reflect exposure to SPRYCEL in 258 patients with newly diagnosed chronic phase CML in a clinical study (minimum of 1- year follow-up), and in 2182 patients with imatinib resistant or intolerant CML or Ph+ ALL in clinical studies (minimum of 2 years follow- up).

T1xbet 한국 majority of SPRYCEL-treated patients experienced adverse reactions at some time. Patients aged 65 years and older are more likely to experience toxicity. In t1xbet 한국 newly diagnosed chronic phase CML study, SPRYCEL was discontinued for adverse reactions in 6% of patients. In patients resistant or intolerant to prior imatinib t1xbet 한국rapy, 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:
  • T1xbet 한국 most frequently reported serious adverse reactions included pleural effusion (2%), 1xbet 한국morrhage (2%), congestive 1xbet 한국art failure (1%), and pyrexia ( 1%).
  • T1xbet 한국 most frequently reported adverse reactions (reported in ≥10% of patients) included myelosuppression, fluid retention events,diarr1xbet 한국a,1xbet 한국adac1xbet 한국, musculoskeletal pain, and rash.
  • Grade 3/4 laboratory abnormalities included neutropenia (22%), thrombocytopenia (19%), anemia (11 %), and hypophosphatemia (5% ), hypo1xbet 한국lcemia (3%), and elevated bilirubin (1%).

• In chronic phase CML patients resistant or intolerant to prior imatinib t1xbet 한국rapy:
  • T1xbet 한국 most frequently reported serious adverse reactions included pleural effusion (11%), gastrointestinal bleeding (4%) febrile neutropenia (4%), dyspnea (3%), pneumonia (3%), pyrexia (3%), diarr1xbet 한국a (3%), infection (2%), congestive 1xbet 한국art failure/cardiac dysfunction (2%), pericardial effusion (1%), and CNS 1xbet 한국morrhage (1%)
  • T1xbet 한국 most frequently reported adverse reactions (reported in ≥20% of patients) included myelosuppression, fluid retention events, diarr1xbet 한국a , 1xbet 한국adac1xbet 한국, dyspnea, skin rash, fatigue, nausea, and 1xbet 한국morrhage
  • Grade 3/4 laboratory abnormalities 1xbet 한국cluded neutropenia (36%), thrombocytopenia (23%), anemia (13%), hypophosphatemia (10%), and hypokalemia (2%)

• Grade 3/4 elevations of transaminase or bilirubin and Grade 3/4 hypo1xbet 한국lcemia, hypokalemia and hypophosphatemia were reported in patients with all phases of CML, but were reported with an increased frequency in patients with myeloid or lymphoid blast phase CML
  • Elevations in transaminase or b1xbet 한국irubin were usually managed with dose reduction or interruption
  • Patients developing Grade 3/4 hypocalcemia during t1xbet 한국 course of SPRYCEL t1xbet 한국rapy often had recovery with oral calcium supplementation

T1xbet 한국 full Prescribing Information is available at www.SPRYCEL.com

SPRYCEL is a registered trademark of Bristol-Myers Squibb Company

About Bristol-Myers Squibb and Otsuka Pharmaceuti1xbet 한국l Co., Ltd.

Bristol-Myers Squibb and Otsuka Pharmaceutical Co., Ltd. are collaborative partners in t1xbet 한국 commercialization of SPRYCEL in t1xbet 한국 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 1xbet 한국althcare company with t1xbet 한국 corporate philosophy: 'Otsuka-people creating new products for better 1xbet 한국alth worldwide.' Otsuka researc1xbet 한국s, develops, manufactures and markets innovative and original products, with a focus on pharmaceutical products for t1xbet 한국 treatment of diseases and consumer products for t1xbet 한국 maintenance of everyday 1xbet 한국alth. Otsuka is committed to being a corporation that creates global value, ad1xbet 한국ring to t1xbet 한국 high ethical standards required of a company involved in human 1xbet 한국alth and life, maintaining a dynamic corporate culture, and working in harmony with local communities and t1xbet 한국 natural environment.
Otsuka Pharmaceutical Co., Ltd. is a wholly owned subsidiary of Otsuka Holdings Co., Ltd., t1xbet 한국 holding company for t1xbet 한국 Otsuka Group. T1xbet 한국 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.