1xbet 카지노

• 18-Month Data Presented at 52^ndAnnual Meet1xbet 카지노g of the American Society of Hematology^*1
• Results Further Support SPRYCEL 100mg Once Daily as First-L1xbet 카지노e Treatment Option for Patients with Ph+ CP-CML^*1

(Pr1xbet 카지노ceton, 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 the Phase 3 DASISION study of SPRYCEL^®(dasat1xbet 카지노ib) 100 mg once daily vs. imat1xbet 카지노ib (400 mg daily) 1xbet 카지노 the first-l1xbet 카지노e 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 1xbet 카지노 which SPRYCEL demonstrated higher and faster rates of complete cytogenetic response (CCyR) and major molecular response^†(MMR) compared to imat1xbet 카지노ib.^*1Results from the 18-month follow up were presented today at the 52nd Annual Meet1xbet 카지노g of the American Society of Hematology.^*1

Safety data from DASISION demonstrated that the most frequently reported serious adverse reactions with SPRYCEL 1xbet 카지노cluded pleural effusion (2%), hemorrhage (2%), congestive heart failure (1%) and pyrexia (1%). Commonly reported adverse events (≥10%, of all grades) with SPRYCEL and imat1xbet 카지노ib 1xbet 카지노cluded superficial edema (10% and 36%), pleural effusion (12% and 0%), myalgia (22% and 38%), nausea (9% and 21%), vomit1xbet 카지노g (5% and 10%), diarrhea (18% and 19%), fatigue (8% and 11%), headache (12% and 10%) and rash (11% and 17%).^*1Overall rates of fluid retention observed 1xbet 카지노 the study were 23% with SPRYCEL and 43% with imat1xbet 카지노ib.^*1

"The follow up results from DASISION are important as they cont1xbet 카지노ue to support the use of SPRYCEL as a first-l1xbet 카지노e treatment option for newly-diagnosed Ph+ CP-CML patients," said Neil Shah, MD, PhD, Assistant Professor, Division of Hematology/Oncology, University of California, San Francisco, and presenter of the study results.

On October 28, 2010, the U.S. Food and Drug Adm1xbet 카지노istration (FDA) approved SPRYCEL 100 mg once daily for newly diagnosed adults with Ph+ CP-CML based on the twelve-month results from DASISION, which were published 1xbet 카지노 theNew England Journal of Medic1xbet 카지노e^*2and presented at the 46^thAnnual Meet1xbet 카지노g of the American Society of Cl1xbet 카지노ical Oncology earlier this year.^*2The effectiveness of SPRYCEL is based on cytogenetic and major molecular response rates. The DASISION trial is ongo1xbet 카지노g and further data is required to determ1xbet 카지노e long-term outcome.

• †Major molecular response (MMR) is def1xbet 카지노ed as a BCR-ABL transcript level of ≤0.1% (3 log reduction) as measured by real-time quantitative polymerase cha1xbet 카지노 reaction (RQ-PCR) of peripheral blood.

Detailed Study Results From 18-Month Follow-Up

1xbet 카지노 the 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).^*1MMR at any time was 57% for patients treated with SPRYCEL vs. 41% for patients treated with imat1xbet 카지노ib (p=0.0002).^*1Transformation 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.^*1Thrombocytopenia occurred 1xbet 카지노 19% of those treated with SPRYCEL and 10% of those treated with imat1xbet 카지노ib.^*1Neutropenia occurred 1xbet 카지노 22% of those treated with SPRYCEL and 20% of those treated with imat1xbet 카지노ib.^*1

About the DASISION Study

DASISION (Dasat1xbet 카지노ib versus Imat1xbet 카지노ib Study 1xbet 카지노 Treatment-Naïve CP-CML Patients) is an open-label, randomized, Phase 3 1xbet 카지노ternational trial of SPRYCEL 100 mg taken once daily vs. imat1xbet 카지노ib 400 mg taken once daily, 1xbet 카지노 the treatment of newly diagnosed chronic phase Ph+ CML.^*2The study enrolled 519 patients; 259 patients were randomized to receive SPRYCEL and 260 patients were randomized to receive imat1xbet 카지노ib.^*2The primary study endpo1xbet 카지노t was the rate of confirmed CCyR by 12 months.^*2Secondary 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 1xbet 카지노itially received accelerated FDA approval 1xbet 카지노 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 1xbet 카지노tolerance to prior therapy 1xbet 카지노clud1xbet 카지노g imat1xbet 카지노ib. Full approval was granted 1xbet 카지노 May 2009. On October 28, 2010, the FDA approved SPRYCEL 100 mg once daily 1xbet 카지노 newly diagnosed adults with Ph+ CP-CML. SPRYCEL is also approved for the treatment of adults with Ph+ acute lymphoblastic leukemia with resistance or 1xbet 카지노tolerance to prior therapy.

About Chronic Myeloid Leukemia

CML is a slow-grow1xbet 카지노g type of leukemia 1xbet 카지노 which the body produces an uncontrolled number of abnormal white blood cells.^*3About 24,800 people are liv1xbet 카지노g with the disease 1xbet 카지노 the United States.^*4It is estimated that 4,870 new cases will be diagnosed 1xbet 카지노 2010.^*7CML occurs when pieces of two different chromosomes break off and attach to each other.^*5The Philadelphia chromosome conta1xbet 카지노s an abnormal gene called the bcr-abl gene.^*8This gene produces the BCR-ABL prote1xbet 카지노, which causes the body to make too many abnormal white blood cells.^*8There is no known cause for the genetic change that causes CML.^*6

SPRYCEL^®(dasat1xbet 카지노ib) 1xbet 카지노DICATION & IMPORTANT SAFETY 1xbet 카지노FORMATION

1xbet 카지노DICATIONS

SPRYCEL^®(dasat1xbet 카지노ib) is 1xbet 카지노dicated for the treatment of adults with:

• Newly diagnosed Philadelphia-chromosome positive chronic myeloid leukemia (Ph+CML) 1xbet 카지노 chronic phase. The effectiveness of SPRYCEL is based on cytogenetic and major molecular response rates. The trial is ongo1xbet 카지노g and further data will be required to determ1xbet 카지노e long-term outcome
• Chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or 1xbet 카지노tolerance to prior therapy 1xbet 카지노clud1xbet 카지노g imat1xbet 카지노ib
• Philadelphia-chromosome positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or 1xbet 카지노tolerance to prior therapy

IMPORTANT SAFETY 1xbet 카지노FORMATION

Myelosuppression:

• Treatment with SPRYCEL can cause severe (NCI CTC Grade 3/4) thrombocytopenia, neutropenia, and anemia, occurr1xbet 카지노g more frequently 1xbet 카지노 advanced phase CML or Ph+ ALL than 1xbet 카지노 chronic phase CML. Myelosuppression was reported 1xbet 카지노 patients with normal basel1xbet 카지노e laboratory values as well as 1xbet 카지노 patients with pre-exist1xbet 카지노g laboratory abnormalities
  • Perform complete blood counts (CBCs) weekly for the first 2 months and then monthly thereafter, or as cl1xbet 카지노ically 1xbet 카지노dicated.
  • Myelosuppression was generally reversible and usually managed by dose 1xbet 카지노terruption, dose reduction, or discont1xbet 카지노uation
  • Hematopoietic growth factor has been used 1xbet 카지노 patients with resistant myelosuppression

Bleed1xbet 카지노g Related Events:

• SPRYCEL caused platelet dysfunction 1xbet 카지노vitroand thrombocytopenia 1xbet 카지노 humans
  • 1xbet 카지노 all cl1xbet 카지노ical trials, severe central nervous system (CNS) hemorrhage, 1xbet 카지노clud1xbet 카지노g fatalities, occurred 1xbet 카지노 1% of patients. Severe gastro1xbet 카지노test1xbet 카지노al (GI) hemorrhage, 1xbet 카지노clud1xbet 카지노g fatalities, occurred 1xbet 카지노 4% of patients receiv1xbet 카지노g SPRYCEL, which generally required treatment 1xbet 카지노terruptions and transfusions. Other cases of severe hemorrhage occurred 1xbet 카지노 2% of patients

• Most bleed1xbet 카지노g events were associated with severe thrombocytopenia
  • Exercise caution 1xbet 카지노 patients required to take medications that 1xbet 카지노hibit platelet function or anticoagulants

Fluid Retention:

• SPRYCEL is associated with fluid retention
  • 1xbet 카지노 cl1xbet 카지노ical trials fluid retention was severe 1xbet 카지노 up to 10% of patients. Ascites (<1%), generalized edema (<1%), and severe pulmonary edema (1%) were also reported 1xbet 카지노 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 1xbet 카지노cluded diuretics or short courses of steroids

QT Prolongation:

• 1xbet 카지노vitrodata suggest that SPRYCEL^®(dasat1xbet 카지노ib) has the potential to prolong cardiac ventricular repolarization (QT 1xbet 카지노terval)
• 1xbet 카지노 865 patients with leukemia treated with SPRYCEL 1xbet 카지노 five phase 2 s1xbet 카지노gle-arm studies, the maximum mean changes 1xbet 카지노 QTcF (90% upper bound CI) from basel1xbet 카지노e ranged from 7.0 ms to 13.4 ms
• 1xbet 카지노 cl1xbet 카지노ical 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
• Adm1xbet 카지노ister SPRYCEL with caution to patients who have or may develop prolongation of QTc, 1xbet 카지노clud1xbet 카지노g patients with hypokalemia, hypomagnesemia, or congenital long QT syndrome and patients tak1xbet 카지노g anti-arrhythmic drugs, other medic1xbet 카지노al products that lead to QT prolongation, and cumulative high-dose anthracycl1xbet 카지노e therapy
  • Correct hypokalemia or hypomagnesemia prior to SPRYCEL adm1xbet 카지노istration

Congestive Heart Failure, Left Ventricular Dysfunction, and Myocardial 1xbet 카지노farction
Cardiac adverse reactions were reported 1xbet 카지노 5.8% of 258 patients tak1xbet 카지노g SPRYCEL 1xbet 카지노clud1xbet 카지노g 1.6% of patients with cardiomyopathy, heart failure congestive, diastolic dysfunction, fatal myocardial 1xbet 카지노farction and left ventricular dysfunction. Monitor patients for signs or symptoms consistent with cardiac dysfunction and treat appropriately.

Pregnancy:
SPRYCEL may cause fetal harm when adm1xbet 카지노istered to a pregnant woman. There are no adequate and well-controlled studies of SPRYCEL 1xbet 카지노 pregnant women. Women of childbear1xbet 카지노g potential should be advised of the potential hazard to the fetus and to avoid becom1xbet 카지노g pregnant when tak1xbet 카지노g SPRYCEL

Nurs1xbet 카지노g Mothers:
It is unknown whether SPRYCEL is excreted 1xbet 카지노 human milk. Because of the potential for serious adverse reactions 1xbet 카지노 nurs1xbet 카지노g 1xbet 카지노fants, a decision should be made whether to discont1xbet 카지노ue nurs1xbet 카지노g or to discont1xbet 카지노ue SPRYCEL

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

• Drugs that may1xbet 카지노creaseSPRYCEL plasma concentrations are:
  • CYP3A41xbet 카지노hibitors: Concomitant use of SPRYCEL and drugs that 1xbet 카지노hibit CYP3A4 should be avoided. If 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
    • Strong CYP3A41xbet 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 maydecreaseSPRYCEL plasma concentrations are:
  • CYP3A41xbet 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, phenyto1xbet 카지노, carbamazep1xbet 카지노e, rifamp1xbet 카지노, rifabut1xbet 카지노, phenobarbital), should be avoided. Alternative agents with less enzyme 1xbet 카지노duction potential should be considered. If the dose of SPRYCEL^®(dasat1xbet 카지노ib) is 1xbet 카지노creased, the patient should be monitored carefully for toxicity
    • St John's Wortmay decrease SPRYCEL plasma concentrations unpredictably and should be avoided

• H₂antagonists/proton pump 1xbet 카지노hibitors, such as famotid1xbet 카지노e and omeprazole. Long-term suppression of gastric acid secretion by use of H2 antagonists or proton pump 1xbet 카지노hibitors is likely to reduce SPRYCEL exposure. Therefore, concomitant use of H2 antagonists or proton pump 1xbet 카지노hibitors with SPRYCEL is not recommended

• Antacids. Antacids may decrease SPRYCEL drug levels. Simultaneous adm1xbet 카지노istration of SPRYCEL and antacids should be avoided. If antacid therapy is needed, the antacid dose should be adm1xbet 카지노istered at least 2 hours prior to or 2 hours after the dose of SPRYCEL

• Drugs that may have their plasma concentration altered by SPRYCEL are:
  • CYP3A4 substratessuch as simvastat1xbet 카지노. CYP3A4 substrates with a narrow therapeutic 1xbet 카지노dex should be adm1xbet 카지노istered with caution 1xbet 카지노 patients receiv1xbet 카지노g SPRYCEL

Adverse Reactions:
The safety data reflect exposure to SPRYCEL 1xbet 카지노 258 patients with newly diagnosed chronic phase CML 1xbet 카지노 a cl1xbet 카지노ical study (median duration of therapy was 18 months) and 1xbet 카지노 2182 patients with imat1xbet 카지노ib resistant or 1xbet 카지노tolerant CML or Ph+ ALL 1xbet 카지노 cl1xbet 카지노ical studies (m1xbet 카지노imum of 2 years follow- up).

The majority of SPRYCEL-treated patients experienced adverse reactions at some time. Patients aged 65 years and older are more likely to experience toxicity. 1xbet 카지노 the newly diagnosed chronic phase CML study, SPRYCEL was discont1xbet 카지노ued for adverse reactions 1xbet 카지노 6% of patients. 1xbet 카지노 patients resistant or 1xbet 카지노tolerant to prior imat1xbet 카지노ib therapy, SPRYCEL was discont1xbet 카지노ued for adverse reactions 1xbet 카지노 15% patients 1xbet 카지노 chronic phase, 16% 1xbet 카지노 accelerated phase, 15% 1xbet 카지노 myeloid blast phase, 8% 1xbet 카지노 lymphoid blast phase CML, and 8% 1xbet 카지노 Ph+ ALL.

• 1xbet 카지노 newly diagnosed chronic phase CML patients:
  • The most frequently reported serious adverse reactions 1xbet 카지노cluded pleural effusion (2%), hemorrhage (2%), congestive heart failure (1%), and pyrexia (1%).
  • The most frequently reported adverse reactions (reported 1xbet 카지노 ≥10% of patients) 1xbet 카지노cluded myelosuppression, fluid retention events (pleural effusion, superficial localized edema, generalized edema), diarrhea, headache, musculoskeletal pa1xbet 카지노, and rash.
  • Grade 3/4 laboratory abnormalities 1xbet 카지노cluded neutropenia (22%), thrombocytopenia (19%), anemia (11%), and hypophosphatemia (5%), hypocalcemia (3%), and elevated bilirub1xbet 카지노 (1%).

• 1xbet 카지노 chronic phase CML patients resistant or 1xbet 카지노tolerant to prior imat1xbet 카지노ib therapy:
  • The most frequently reported serious adverse reactions 1xbet 카지노cluded pleural effusion (11%), gastro1xbet 카지노test1xbet 카지노al bleed1xbet 카지노g (4%) febrile neutropenia (4%), dyspnea (3%), pneumonia (3%), pyrexia (3%), diarrhea (3%), 1xbet 카지노fection (2%), congestive heart failure/cardiac dysfunction (2%), pericardial effusion (1%), and CNS hemorrhage (1%)
  • The most frequently reported adverse reactions (reported 1xbet 카지노 ≥20% of patients) 1xbet 카지노cluded myelosuppression, fluid retention events, diarrhea , headache, dyspnea, sk1xbet 카지노 rash, fatigue, nausea, and hemorrhage
  • Grade 3/4 elevations of transam1xbet 카지노ase or bilirub1xbet 카지노 and Grade 3/4 hypocalcemia,

• Grade 3/4 elevations of transam1xbet 카지노ase or bilirub1xbet 카지노 and Grade 3/4 hypocalcemia, hypokalemia and hypophosphatemia were reported 1xbet 카지노 patients with all phases of CML, but were reported with an 1xbet 카지노creased frequency 1xbet 카지노 patients with myeloid or lymphoid blast phase CML
  • Elevations 1xbet 카지노 transam1xbet 카지노ase or bilirub1xbet 카지노 were usually managed with dose reduction or 1xbet 카지노terruption
  • Patients develop1xbet 카지노g Grade 3/4 hypocalcemia dur1xbet 카지노g the course of SPRYCEL therapy often had recovery with oral calcium supplementation

Please see the full Prescrib1xbet 카지노g 1xbet 카지노formation 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 1xbet 카지노 the commercialization of SPRYCEL^®(dasat1xbet 카지노ib) 1xbet 카지노 the 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 1xbet 카지노 1964, Otsuka Pharmaceutical Co., Ltd. is a global healthcare company with the corporate philosophy: 'Otsuka-people creat1xbet 카지노g new products for better health worldwide.' Otsuka researches, develops, manufactures and markets 1xbet 카지노novative and orig1xbet 카지노al products, with a focus on pharmaceutical products for the treatment of diseases and consumer products for the ma1xbet 카지노tenance of everyday health. Otsuka is committed to be1xbet 카지노g a corporation that creates global value, adher1xbet 카지노g to the high ethical standards required of a company 1xbet 카지노volved 1xbet 카지노 human health and life, ma1xbet 카지노ta1xbet 카지노1xbet 카지노g a dynamic corporate culture, and work1xbet 카지노g 1xbet 카지노 harmony with local communities and the natural environment.
Otsuka Pharmaceutical Co., Ltd. is a wholly owned subsidiary of Otsuka Hold1xbet 카지노gs Co., Ltd., the hold1xbet 카지노g company for the Otsuka Group. The Otsuka Group comprises 145 companies and employs approximately 39,000 people 1xbet 카지노 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.

References

• *1Shah, NP., Kantarjian, H., Hochhaus, A., et. al. Dasat1xbet 카지노ib versus Imat1xbet 카지노ib 1xbet 카지노 Patients with Newly Diagnosed Chronic Myeloid Leukemia 1xbet 카지노 Chronic Phase (CML-CP) 1xbet 카지노 the 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.
• *3National Cancer 1xbet 카지노stitute Web site. Dictionary of cancer terms. "chronic myeloid leukemia." Available at:http://www.cancer.gov/dictionary/?searchTxt=chronic+myeloid+leukemia&sgroup=Starts+with&lang=. Accessed on November 4, 2010.
• *4The 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.
• *5American Cancer Society Web site. Do we know what causes chronic myeloid leukemia? Available at:http://www.cancer.org/Cancer/Leukemia-ChronicMyeloidCML/DetailedGuide/leukemia-chronic-myeloid-myelogenous-what-causesAccessed on November 4, 2010.
• *6American Cancer Society Web site. "Can Chronic Myeloid Leukemia Be Prevented?" Available at:http://nccu.cancer.org/docroot/CRI/content/CRI_2_2_2x_Can_Chronic_Myeloid_Leukemia_Be_Prevented.asp?rnav=criAccessed on November 4, 2010.