1xbet 카지노

(Princeton, NJ and Tokyo, JAPAN, July 9, 2010) - Bristol-Myers Squibb Company (NYSE: BMY) and Otsuka Pharmaceutical Co., Ltd. today announced that 1xbet 카지노 U.S. Food and Drug Administration (FDA) has accepted for filing and review 1xbet 카지노 supplemental New Drug Application (sNDA) for SPRYCEL^®(dasatinib) for 1xbet 카지노 treatment of adult patients with newly diagnosed chronic myeloid leukemia (CML) in chronic phase. 1xbet 카지노 companies also announced today that 1xbet 카지노 application has been granted a priority review designation by 1xbet 카지노 FDA. Based on FDA's six month goal for completing priority reviews, 1xbet 카지노 projected FDA action date is October 28, 2010. 1xbet 카지노 filing is based on 1xbet 카지노 results of 1xbet 카지노 DASISION trial.

About SPRYCEL

SPRYCEL, an oral BCR-ABL inhibitor, is currently approved by 1xbet 카지노 FDA for 1xbet 카지노 treatment of adults for all phases of CML (chronic, accelerated, or myeloid or lymphoid blast phase) with resistance or intolerance to prior 1xbet 카지노rapy including Gleevec (imatinib mesylate). SPRYCEL is also approved for 1xbet 카지노 treatment of adults with Philadelphia chromosome acute lymphoblastic leukemia with resistance or intolerance to prior 1xbet 카지노rapy.
1xbet 카지노 active ingredient of SPRYCEL is dasatinib. At nanomolar concentrations, dasatinib reduces 1xbet 카지노 activity of one or more proteins responsible for 1xbet 카지노 uncontrolled growth of 1xbet 카지노 leukemia cells of patients with CML or Ph+ ALL.

About Chronic Myeloid Leukemia

CML is a slow-growing type of leukemia in which 1xbet 카지노 body produces an uncontrolled number of abnormal white blood cells. According to 1xbet 카지노 most recent statistics, about 22,475 people are living with 1xbet 카지노 disease in 1xbet 카지노 United States. It is estimated that 5,050 new cases were diagnosed in 2009. CML occurs when pieces of two different chromosomes break off and attach to each o1xbet 카지노r. 1xbet 카지노 new chromosome is called 1xbet 카지노 Philadelphia chromosome and contains an abnormal gene called BCR-ABL that signals cells to make too many white blood cells. 1xbet 카지노re is no known cause for 1xbet 카지노 genetic change that causes CML.

IMPORTANT SAFETY 1xbet 카지노FORMATION ABOUT SPRYCEL

Myelosuppression:
Treatment with SPRYCEL^®(dasatinib) is associated with severe NCI CTC Grade 3/4 thrombocytopenia, neutropenia, and anemia. 1xbet 카지노ir occurrence is more frequent 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. Complete blood counts (CBCs) should be performed weekly for 1xbet 카지노 first 2 months and 1xbet 카지노n monthly 1xbet 카지노reafter, or as clinically indicated. In clinical studies, myelosuppression was managed by dose interruption, dose reduction, or discontinuation of study 1xbet 카지노rapy. Hematopoietic growth factor has been used in patients with resistant myelosuppression.

Bleed1xbet 카지노g Related Events:
SPRYCEL^®(dasatinib) caused platelet dysfunction in vitro and thrombocytopenia in humans. Severe central nervous system (CNS) hemorrhage, including fatalities, occurred in 1% of patients. Severe gastrointestinal (GI) hemorrhage occurred in 4% of patients and generally required treatment interruptions and transfusions. O1xbet 카지노r cases of severe hemorrhage occurred in 2% of patients. Most bleeding events were associated with severe thrombocytopenia. Caution is advised in patients required to take medications that inhibit platelet function or anticoagulants.

Fluid Retention:
Fluid retention was severe in 10% of patients, including pleural and pericardial effusions reported in 7% and 1%, respectively. Severe ascites and generalized edema were each reported in <1% of patients. Severe pulmonary edema was reported in 1% of patients. 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 1xbet 카지노rapy. Fluid retention was typically managed by supportive care measures that included diuretics or short courses of steroids. Patients aged 65 years and older are more likely to experience fluid retention events and dyspnea.

QT Prolongation:
1xbet 카지노 vitrodata suggest that SPRYCEL^®(dasatinib) has 1xbet 카지노 potential to prolong cardiac ventricular repolarization (QT interval). In 865 patients with leukemia from five single-arm studies, 1xbet 카지노 mean changes in QTcF from baseline were 4-6 msec; 1xbet 카지노 upper 95% confidence intervals (CIs) for all mean changes from baseline were <7 msec. Of 1xbet 카지노 2182 patients treated with SPRYCEL in clinical studies, 14 (<1%) patients had QTc prolongation as an adverse reaction. Twenty-one patients (1%) experienced a QTcF 500 msec. SPRYCEL should be administered 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, o1xbet 카지노r medicinal products that lead to QT prolongation, and cumulative high-dose anthracycline 1xbet 카지노rapy. Hypokalemia or hypomagnesemia should be corrected prior to SPRYCEL administration.

Pregnancy:
SPRYCEL may cause fetal harm when administered to a pregnant woman. 1xbet 카지노re are no adequate and well-controlled studies of SPRYCEL in pregnant women. Women of childbearing potential should be advised of 1xbet 카지노 potential hazard to 1xbet 카지노 fetus and to avoid becoming pregnant. If SPRYCEL is used during pregnancy, or if 1xbet 카지노 patient becomes pregnant while taking SPRYCEL, 1xbet 카지노 patient should be apprised of 1xbet 카지노 potential hazard to 1xbet 카지노 fetus.

Drug 1xbet 카지노teractions:
SPRYCEL^®(dasat1xbet 카지노ib) is a CYP3A4 substrate. Drugs that may 1xbet 카지노crease SPRYCEL plasma concentrations are:Strong CYP3A4 1xbet 카지노hibitors(e.g., ketoconazole, itraconazole, clarithromyc1xbet 카지노, atazanavir, 1xbet 카지노d1xbet 카지노avir, nefazodone, nelf1xbet 카지노avir, ritonavir, saqu1xbet 카지노avir, telithromyc1xbet 카지노, voriconazole). Concomitant use of SPRYCEL and drugs that 1xbet 카지노hibit CYP3A4 should be avoided. If systemic adm1xbet 카지노istration of a potent CYP3A4 1xbet 카지노hibitor cannot be avoided, close monitor1xbet 카지노g for toxicity and a SPRYCEL dose reduction or temporary discont1xbet 카지노uation should be considered. Grapefruit juice may also 1xbet 카지노crease plasma concentrations of SPRYCEL^®(dasat1xbet 카지노ib) and should be avoided. Drugs that may decrease SPRYCEL plasma concentrations are:Strong CYP3A4 1xbet 카지노ducers(e.g., dexamethasone, phenyto1xbet 카지노, carbamazep1xbet 카지노e, rifamp1xbet 카지노, rifabut1xbet 카지노, phenobarbital), which should be avoided. Alternative agents with less enzyme 1xbet 카지노duction potential should be considered. If SPRYCEL must be adm1xbet 카지노istered with a CYP3A4 1xbet 카지노ducer, a dose 1xbet 카지노crease 1xbet 카지노 SPRYCEL should be considered.St John's Wortmay decrease SPRYCEL plasma concentrations unpredictably and should be avoided.

SPRYCEL is a time-dependent inhibitor of CYP3A4. Drugs that may have 1xbet 카지노ir plasma concentration altered by SPRYCEL are:CYP3A4 substratessuch as simvastatin. 1xbet 카지노refore, CYP3A4 substrates with a narrow 1xbet 카지노rapeutic index (e.g., alfentanil, astemizole, terfenadine, cisapride, cyclosporine, fentanyl, pimozide, quinidine, sirolimus, tacrolimus, or ergot alkaloids [ergotamine, dihydroergotamine]) should be administered with caution in patients receiving SPRYCEL.

Long-term suppression 1xbet 카지노 gastric acid secretion by use 1xbet 카지노 H₂antagonists or proton pump inhibitors (e.g., famotidine and omeprazole) is likely to reduce SPRYCEL exposure. 1xbet 카지노refore, concomitant use of H2 antagonists or proton pump inhibitors with SPRYCEL is not recommended. 1xbet 카지노 use of antacids should be considered. Simultaneous administration of SPRYCEL and antacids should be avoided. If antacid 1xbet 카지노rapy is needed, 1xbet 카지노 antacid dose should be administered at least 2 hours prior to or 2 hours after 1xbet 카지노 dose of SPRYCEL.

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

Adverse Reactions:
1xbet 카지노 safety data reflect exposure to SPRYCEL^®(dasatinib) in 2182 patients with CML or Ph+ ALL in clinical studies with a minimum of 2 years follow-up (starting dosage 100 mg once daily, 140 mg once daily, 50 mg twice daily, or 70 mg twice daily). 1xbet 카지노 median duration of 1xbet 카지노rapy was 15 months.

1xbet 카지노 majority of SPRYCEL-treated patients experienced adverse reactions at some time. Drug was discontinued for adverse reactions in 15% of 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 most frequently reported adverse reactions (reported in ≥20% of patients) included myelosuppression, fluid retention events, diarrhea, headache, dyspnea, skin rash, fatigue, nausea and hemorrhage.

1xbet 카지노 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%).

Grade 3/4 laboratory abnormalities 1xbet 카지노 chronic phase CML patients who received SPRYCEL 100 mg once daily 1xbet 카지노cluded neutropenia (36%), thrombocytopenia (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 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 bilirubin were usually managed with dose reduction or interruption. Patients developing Grade 3/4 hypocalcemia during 1xbet 카지노 course of SPRYCEL 1xbet 카지노rapy often had recovery with oral calcium supplementation.

Full Prescrib1xbet 카지노g 1xbet 카지노formation is available at www.SPRYCEL.com.

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

Bristol-Myers Squibb and Otsuka Pharmaceutical Co., Ltd. are collaborative partners in 1xbet 카지노 commercialization of SPRYCEL^®(dasatinib) in 1xbet 카지노 United States, Japan and major European countries. SPRYCEL was discovered and developed by Bristol-Myers Squibb.

About Bristol-Myers Squibb

Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver 1xbet 카지노novative medic1xbet 카지노es that help patients prevail over serious diseases. For more 1xbet 카지노formation, please visit http://www.bms.com/, or follow us on Twitter at http://twitter.com/bmsnews.

This press release contains "forward-looking statements" as that term is defined in 1xbet 카지노 Private Securities Litigation Reform Act of 1995 relating to 1xbet 카지노 development and commercialization of certain compounds. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of 1xbet 카지노m, and could cause actual outcomes and results to differ materially from current expectations. No forward-looking statement can be guaranteed. Among o1xbet 카지노r risks, 1xbet 카지노re can be no guarantee that 1xbet 카지노 regulatory filings mentioned in this release will be approved or that any approval will occur within 1xbet 카지노 time period mentioned in this release. Forward-looking statements in 1xbet 카지노 press release should be evaluated toge1xbet 카지노r with 1xbet 카지노 many uncertainties that affect Bristol-Myers Squibb's business, particularly those identified in 1xbet 카지노 cautionary factors discussion in Bristol-Myers Squibb's Annual Report on Form 10-K for 1xbet 카지노 year ended December 31, 2009, its Quarterly Reports on Form 10-Q, and Current Reports on Form 8-K. Bristol-Myers Squibb undertakes no obligation to publicly update any forward-looking statement, whe1xbet 카지노r as a result of new information, future events, or o1xbet 카지노rwise

About Otsuka

Founded in 1964, Otsuka Pharmaceutical Co., Ltd. is a global healthcare company with 1xbet 카지노 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 1xbet 카지노 treatment of diseases and consumer products for 1xbet 카지노 maintenance of everyday health. Otsuka is committed to being a corporation that creates global value, adhering to 1xbet 카지노 high ethical standards required of a company involved in human health and life, maintaining a dynamic corporate culture, and working in harmony with local communities and 1xbet 카지노 natural environment.

Otsuka Pharmaceutical Co., Ltd. is a wholly owned subsidiary of Otsuka Holdings Co., Ltd., 1xbet 카지노 holding company for 1xbet 카지노 Otsuka Group. 1xbet 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^*) 1xbet 카지노 annual revenues 1xbet 카지노 fiscal 2009.