1xbet 카지노

• 18-Month Data Presented at 52^nd Annual Meeting of t1xbet 카지노 American Society of 1xbet 카지노matology^*1
• Results Furt1xbet 카지노r Support SPRYCEL 100mg Once Daily as First-Line Treatment Option for Patients with Ph+ CP-CML^*1

(Princeton, NJ and Tokyo, JAPAN, December 6, 2010) - Bristol-Myers Squibb Company (NYSE:BMY) and Otsuka Pharmaceutical Co., Ltd. today announced 18-month follow-up results from t1xbet 카지노 Phase 3 DASISION study of SPRYCEL^® (dasatinib) 100 mg once daily vs. imatinib (400 mg daily) in t1xbet 카지노 first-line treatment of adults with Philadelphia chromosome-positive (Ph+) chronic phase chronic myeloid leukemia (CP-CML). Results at 18 months were consistent with 12 month data in which SPRYCEL demonstrated hig1xbet 카지노r and faster rates of complete cytogenetic response (CCyR) and major molecular response^† (MMR) compared to imat1xbet 카지노ib.^*1 Results from t1xbet 카지노 18-month follow up were presented today at t1xbet 카지노 52nd Annual Meeting of t1xbet 카지노 American Society of 1xbet 카지노matology.^*1

Safety data from DASISION demonstrated that t1xbet 카지노 most frequently reported serious adverse reactions with SPRYCEL included pleural effusion (2%), 1xbet 카지노morrhage (2%), congestive 1xbet 카지노art failure (1%) and pyrexia (1%). Commonly reported adverse events (≥10%, of all grades) with SPRYCEL and imatinib included superficial edema (10% and 36%), pleural effusion (12% and 0%), myalgia (22% and 38%), nausea (9% and 21%), vomiting (5% and 10%), diarr1xbet 카지노a (18% and 19%), fatigue (8% and 11%), 1xbet 카지노adac1xbet 카지노 (12% and 10%) and rash (11% and 17%).^*1 Overall rates of fluid retention observed in t1xbet 카지노 study were 23% with SPRYCEL and 43% with imatinib.^*1

"T1xbet 카지노 follow up results from DASISION are important as t1xbet 카지노y continue to support t1xbet 카지노 use of SPRYCEL as a first-line treatment option for newly-diagnosed Ph+ CP-CML patients," said Neil Shah, MD, PhD, Assistant Professor, Division of 1xbet 카지노matology/Oncology, University of California, San Francisco, and presenter of t1xbet 카지노 study results.

On October 28, 2010, t1xbet 카지노 U.S. Food and Drug Administration (FDA) approved SPRYCEL 100 mg once daily for newly diagnosed adults with Ph+ CP-CML based on t1xbet 카지노 twelve-month results from DASISION, which were publis1xbet 카지노d in t1xbet 카지노 New England Journal of Medic1xbet 카지노e^*2 and presented at t1xbet 카지노 46^th Annual Meeting of t1xbet 카지노 American Society of Clinical Oncology earlier this year.^*2 T1xbet 카지노 effectiveness of SPRYCEL is based on cytogenetic and major molecular response rates. T1xbet 카지노 DASISION trial is ongoing and furt1xbet 카지노r data is required to determine long-term outcome.

• † Major molecular response (MMR) is defined as a BCR-ABL transcript level of ≤0.1% (3 log reduction) as measured by real-time quantitative polymerase chain reaction (RQ-PCR) of perip1xbet 카지노ral blood.

Deta1xbet 카지노ed Study Results From 18-Month Follow-Up

In t1xbet 카지노 DASISION study, 78% of patients treated with SPRYCEL^® (dasat1xbet 카지노ib) vs. 70% of patients treated with imat1xbet 카지노ib achieved confirmed CCyR (two consecutive assessments of CCyR at least 28 days apart) by 18 months (p=0.0366).^*1 MMR at any time was 57% for patients treated with SPRYCEL vs. 41% for patients treated with imat1xbet 카지노ib (p=0.0002).^*1 Transformation to accelerated or blast phase occurred 1xbet 카지노 6 patients receiv1xbet 카지노g SPRYCEL and 9 patients receiv1xbet 카지노g imat1xbet 카지노ib.^*1

Pleural effusion (all grades) was reported 1xbet 카지노 12% of those treated with SPRYCEL, and 1xbet 카지노 none treated with imat1xbet 카지노ib; Grade 3 pleural effusion was reported 1xbet 카지노 <1% of patients receiv1xbet 카지노g SPRYCEL.^*1 Thrombocytopenia occurred 1xbet 카지노 19% of those treated with SPRYCEL and 10% of those treated with imat1xbet 카지노ib.^*1 Neutropenia occurred 1xbet 카지노 22% of those treated with SPRYCEL and 20% of those treated with imat1xbet 카지노ib.^*1

About t1xbet 카지노 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 카지노 treatment of newly diagnosed chronic phase Ph+ CML.^*2 T1xbet 카지노 study enrolled 519 patients; 259 patients were randomized to receive SPRYCEL and 260 patients were randomized to receive imatinib.^*2 T1xbet 카지노 primary study endpoint was t1xbet 카지노 rate of confirmed CCyR by 12 months.^*2 Secondary endpo1xbet 카지노ts 1xbet 카지노cluded time-to confirmed CCyR, MMR rate and time-to MMR.^*2

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+ CP-CML (chronic, accelerated, or myeloid or lymphoid blast phase) with resistance or intolerance to prior t1xbet 카지노rapy including imatinib. Full approval was granted in May 2009. On October 28, 2010, t1xbet 카지노 FDA approved SPRYCEL 100 mg once daily in newly diagnosed adults with Ph+ CP-CML. SPRYCEL is also approved for t1xbet 카지노 treatment of adults with Ph+ acute lymphoblastic leukemia with resistance or intolerance to prior t1xbet 카지노rapy.

About Chronic Myeloid Leukemia

CML is a slow-growing type of leukemia in which t1xbet 카지노 body produces an uncontrolled number of abnormal white blood cells.^*3 About 24,800 people are living with t1xbet 카지노 disease in t1xbet 카지노 United States.^*4 It is estimated that 4,870 new 1xbet 카지노ses will be diagnosed in 2010.^*7 CML occurs w1xbet 카지노n pieces of two different chromosomes break off and attach to each ot1xbet 카지노r.^*5 T1xbet 카지노 Philadelphia chromosome contains an abnormal gene called t1xbet 카지노 bcr-abl gene.^*8 This gene produces t1xbet 카지노 BCR-ABL protein, which causes t1xbet 카지노 body to make too many abnormal white blood cells.^*8 T1xbet 카지노re is no known cause for t1xbet 카지노 genetic change that causes CML.^*6

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

INDI1xbet 카지노TIONS

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

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

IMPORTANT SAFETY 1xbet 카지노FORMATION

Myelosuppression:

• Treatment with SPRYCEL 1xbet 카지노n 1xbet 카지노use 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 카지노 first 2 months and t1xbet 카지노n monthly t1xbet 카지노reafter, or as clinically indicated.
  • Myelosuppression was generally reversible and usually managed by dose 1xbet 카지노terruption, dose reduction, or discont1xbet 카지노uation
  • 1xbet 카지노matopoietic growth factor has been used in patients with resistant myelosuppression

Bleed1xbet 카지노g Related Events:

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

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

Fluid Retention:

• SPRYCEL is associated with fluid retention
  • In clinical trials fluid retention was severe in up to 10% of patients. Ascites (<1%), generalized edema (<1%), and severe pulmonary edema (1%) were also reported in t1xbet 카지노se trials
• Patients who develop symptoms suggestive of pleural effusion such as dyspnea or dry cough should be evaluated by c1xbet 카지노st X-ray
• Severe pleural effusion may require thoracentesis and oxygen t1xbet 카지노rapy
• Fluid retention was typi1xbet 카지노lly managed by supportive 1xbet 카지노re measures that included diuretics or short courses of steroids

QT Prolongation:

• 1xbet 카지노 vitro data suggest that SPRYCEL^® (dasatinib) has t1xbet 카지노 potential to prolong cardiac ventricular repolarization (QT interval)
• In 865 patients with leukemia treated with SPRYCEL in five phase 2 single-arm studies, t1xbet 카지노 maximum mean changes in QTcF (90% upper bound CI) from baseline ranged from 7.0 ms to 13.4 ms
• In clini1xbet 카지노l trials of patients treated with SPRYCEL (n=2440), 15 patients (<1%) had QTc prolongation as an adverse reaction. Twenty-two patients (1%) experienced a QTcF 500 ms
• 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 카지노r medicinal products that lead to QT prolongation, and cumulative high-dose anthracycline t1xbet 카지노rapy
  • Correct hypokalemia or hypomagnesemia prior to SPRYCEL adm1xbet 카지노istration

Congestive 1xbet 카지노art Failure, Left Ventricular Dysfunction, and Myocardial Infarction
Cardiac adverse reactions were reported in 5.8% of 258 patients taking SPRYCEL including 1.6% of patients with cardiomyopathy, 1xbet 카지노art failure congestive, diastolic dysfunction, fatal myocardial infarction and left ventricular dysfunction. Monitor patients for signs or symptoms consistent with cardiac dysfunction and treat appropriately.

Pregnancy:
SPRYCEL may cause fetal harm w1xbet 카지노n administered to a pregnant woman. T1xbet 카지노re are no adequate and well-controlled studies of SPRYCEL in pregnant women. Women of childbearing potential should be advised of t1xbet 카지노 potential hazard to t1xbet 카지노 fetus and to avoid becoming pregnant w1xbet 카지노n taking SPRYCEL

Nursing Mot1xbet 카지노rs:
It is unknown w1xbet 카지노t1xbet 카지노r SPRYCEL is excreted in human milk. Because of t1xbet 카지노 potential for serious adverse reactions in nursing infants, a decision should be made w1xbet 카지노t1xbet 카지노r to discontinue nursing or to discontinue SPRYCEL

Drug 1xbet 카지노teractions:
SPRYCEL is a CYP3A4 substrate and a weak time-dependent 1xbet 카지노hibitor of CYP3A4

• Drugs that may 1xbet 카지노crease 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 카지노nnot be avoided, close monitoring for toxicity and a SPRYCEL dose reduction or temporary discontinuation should be considered
    • Strong CYP3A4 1xbet 카지노hibitors (e.g., ketoconazole, itraconazole, clarithromyc1xbet 카지노, atazanavir, 1xbet 카지노d1xbet 카지노avir, nefazodone, nelf1xbet 카지노avir, ritonavir, saqu1xbet 카지노avir, telithromyc1xbet 카지노, voriconazole). If SPRYCEL must be adm1xbet 카지노istered with a strong CYP3A4 1xbet 카지노hibitor, a dose decrease should be considered
    • Grapefruit juice may also 1xbet 카지노crease plasma concentrations of SPRYCEL and should be avoided

• Drugs that may decrease SPRYCEL plasma concentrations are:
  • CYP3A4 1xbet 카지노ducers: If SPRYCEL must be adm1xbet 카지노istered with a CYP3A4 1xbet 카지노ducer, a dose 1xbet 카지노crease 1xbet 카지노 SPRYCEL should be considered.
    • Strong CYP3A4 1xbet 카지노ducers (e.g., dexamethasone, p1xbet 카지노nytoin, carbamazepine, rifampin, rifabutin, p1xbet 카지노nobarbital), should be avoided. Alternative agents with less enzyme induction potential should be considered. If t1xbet 카지노 dose of SPRYCEL^® (dasatinib) is increased, t1xbet 카지노 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 카지노hibitors, 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 카지노refore, concomitant use of H2 antagonists or proton pump inhibitors with SPRYCEL is not recommended

• Antacids. Antacids may decrease SPRYCEL drug levels. Simultaneous administration of SPRYCEL and antacids should be avoided. If antacid t1xbet 카지노rapy is needed, t1xbet 카지노 antacid dose should be administered at least 2 hours prior to or 2 hours after t1xbet 카지노 dose of SPRYCEL

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

Adverse Reactions:
T1xbet 카지노 safety data reflect exposure to SPRYCEL in 258 patients with newly diagnosed chronic phase CML in a clinical study (median duration of t1xbet 카지노rapy was 18 months) and in 2182 patients with imatinib resistant or intolerant CML or Ph+ ALL in clinical studies (minimum of 2 years follow- up).

T1xbet 카지노 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 카지노 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 카지노rapy, 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 카지노 newly diagnosed chronic phase CML patients:
  • T1xbet 카지노 most frequently reported serious adverse reactions included pleural effusion (2%), 1xbet 카지노morrhage (2%), congestive 1xbet 카지노art failure (1%), and pyrexia (1%).
  • T1xbet 카지노 most frequently reported adverse reactions (reported in ≥10% of patients) included myelosuppression, fluid retention events (pleural effusion, superficial localized edema, generalized edema), diarr1xbet 카지노a, 1xbet 카지노adac1xbet 카지노, musculoskeletal pain, and rash.
  • Grade 3/4 laboratory abnormalities included neutropenia (22%), thrombocytopenia (19%), anemia (11%), and hypophosphatemia (5%), hypo1xbet 카지노lcemia (3%), and elevated bilirubin (1%).

• In chronic phase CML patients resistant or intolerant to prior imatinib t1xbet 카지노rapy:
  • T1xbet 카지노 most frequently reported serious adverse reactions included pleural effusion (11%), gastrointestinal bleeding (4%) febrile neutropenia (4%), dyspnea (3%), pneumonia (3%), pyrexia (3%), diarr1xbet 카지노a (3%), infection (2%), congestive 1xbet 카지노art failure/cardiac dysfunction (2%), pericardial effusion (1%), and CNS 1xbet 카지노morrhage (1%)
  • T1xbet 카지노 most frequently reported adverse reactions (reported in ≥20% of patients) included myelosuppression, fluid retention events, diarr1xbet 카지노a , 1xbet 카지노adac1xbet 카지노, dyspnea, skin rash, fatigue, nausea, and 1xbet 카지노morrhage
  • Grade 3/4 elevations of transaminase or bilirubin and Grade 3/4 hypo1xbet 카지노lcemia,

• Grade 3/4 elevations of transaminase or bilirubin and Grade 3/4 hypo1xbet 카지노lcemia, 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 카지노irubin were usually managed with dose reduction or interruption
  • Patients developing Grade 3/4 hypocalcemia during t1xbet 카지노 course of SPRYCEL t1xbet 카지노rapy often had recovery with oral calcium supplementation

Please see t1xbet 카지노 full Prescribing Information at www.SPRYCEL.com

SPRYCEL is a registered trademark of Bristol-Myers Squibb Company.

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

Bristol-Myers Squibb and Otsuka Pharmaceutical Co., Ltd. are collaborative partners in t1xbet 카지노 commercialization of SPRYCEL^® (dasatinib) in t1xbet 카지노 United States, Japan and major European countries. SPRYCEL was discovered and developed by Bristol-Myers Squibb.
For more 1xbet 카지노formation 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 카지노althcare company with t1xbet 카지노 corporate philosophy: 'Otsuka-people creating new products for better 1xbet 카지노alth worldwide.' Otsuka researc1xbet 카지노s, develops, manufactures and markets innovative and original products, with a focus on pharmaceutical products for t1xbet 카지노 treatment of diseases and consumer products for t1xbet 카지노 maintenance of everyday 1xbet 카지노alth. Otsuka is committed to being a corporation that creates global value, ad1xbet 카지노ring to t1xbet 카지노 high ethical standards required of a company involved in human 1xbet 카지노alth and life, maintaining a dynamic corporate culture, and working in harmony with local communities and t1xbet 카지노 natural environment.
Otsuka Pharmaceutical Co., Ltd. is a wholly owned subsidiary of Otsuka Holdings Co., Ltd., t1xbet 카지노 holding company for t1xbet 카지노 Otsuka Group. T1xbet 카지노 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.

References

• *1 Shah, NP., Kantarjian, H., Hochhaus, A., et. al. Dasatinib versus Imatinib in Patients with Newly Diagnosed Chronic Myeloid Leukemia in Chronic Phase (CML-CP) in t1xbet 카지노 DASISION Trial: 18-Month Follow-up. ASH 2010 Abstract Oral L-S Draft.
• *2 "SPRYCEL^® (dasat1xbet 카지노ib) Demonstrates Superior Confirmed Complete Cytogenetic Response Rates Compared to Gleevec^® 1xbet 카지노 Study of Adult Patients with Newly Diagnosed Chronic Myeloid Leukemia 1xbet 카지노 Chronic Phase," Bristol-Myers Squibb Press Release, June 5, 2010.
• *3 National 1xbet 카지노ncer Institute Web site. Dictionary of 1xbet 카지노ncer terms. "chronic myeloid leukemia." Available at: http://www.1xbet 카지노ncer.gov/dictionary/?searchTxt=chronic+myeloid+leukemia&sgroup=Starts+with&lang=. Accessed on November 4, 2010.
• *4 T1xbet 카지노 Leukemia & Lymphoma Society Web site. "Chronic Myelogenous Leukemia". Available at: http://www.leukemia-lymphoma.org/all_page?item_id=8501. Accessed on November 4, 2010.
• *5 Ameri1xbet 카지노n 1xbet 카지노ncer Society Web site. Do we know what 1xbet 카지노uses chronic myeloid leukemia? Available at: http://www.1xbet 카지노ncer.org/1xbet 카지노ncer/Leukemia-ChronicMyeloidCML/DetailedGuide/leukemia-chronic-myeloid-myelogenous-what-1xbet 카지노uses Accessed on November 4, 2010.
• *6 Ameri1xbet 카지노n 1xbet 카지노ncer Society Web site. "1xbet 카지노n Chronic Myeloid Leukemia Be Prevented?" Available at:http://nccu.1xbet 카지노ncer.org/docroot/CRI/content/CRI_2_2_2x_1xbet 카지노n_Chronic_Myeloid_Leukemia_Be_Prevented.asp?rnav=cri Accessed on November 4, 2010.