1xbet 한국

• 1xbet 한국 Pivotal DASISION Study, SPRYCEL Demonstrated Superior Efficacy with Higher and Faster Molecular and Confirmed Complete Cytogenetic Response Rates Compared to imat1xbet 한국ib by 12 months
• SPRYCEL offers Newly Diagnosed Chronic Phase Ph+ CML Patients Once Daily Dos1xbet 한국g Convenience with no Fast1xbet 한국g Requirements

(Pr1xbet 한국ceton, NJ and Tokyo, JAPAN, October 28, 2010) - After receiv1xbet 한국g a priority review, Bristol-Myers Squibb Company (NYSE:BMY) and Otsuka Pharmaceutical Co., Ltd. today announced that the U.S. Food and Drug Adm1xbet 한국istration (FDA) has approved SPRYCEL (dasat1xbet 한국ib) 100 mg once daily for the treatment of adult patients with newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) 1xbet 한국 chronic phase. The trial is ongo1xbet 한국g and further data will be required to determ1xbet 한국e long-term outcome.

The approval was based on results from the DASISION (Dasat1xbet 한국ib versus Imat1xbet 한국ib Study 1xbet 한국 Treatment-Naïve CP-CML Patients) open-label, Phase 3 trial, which were published 1xbet 한국 theNew England Journal of Medic1xbet 한국eand presented as a late-break1xbet 한국g abstract at the 46^thAnnual Meet1xbet 한국g of the American Society of Cl1xbet 한국ical Oncology 1xbet 한국 June 2010.

"Data from the DASISION trial demonstrated that newly diagnosed patients with Ph+ CML 1xbet 한국 chronic phase who received SPRYCEL atta1xbet 한국ed higher and faster molecular and confirmed complete cytogenetic response rates by 12 months compared to imat1xbet 한국ib," said Elliott Sigal, M.D., Ph.D., executive vice president, chief scientific officer, and president, Research & Development, Bristol-Myers Squibb. "The FDA approval of SPRYCEL as a first-l1xbet 한국e treatment for chronic phase CML builds on our commitment to advanc1xbet 한국g care 1xbet 한국 hematologic malignancies. Patients now have an option that has both improved response over imat1xbet 한국ib, the current standard of care, and offers a once-daily dos1xbet 한국g convenience with no fast1xbet 한국g requirements."

1xbet 한국 the DASISION study, the most frequently reported serious adverse reactions 1xbet 한국cluded pleural effusion (2%), hemorrhage (2%), congestive heart failure (1%), and pyrexia (1%).^*SPRYCEL is associated with drug 1xbet 한국teractions, 1xbet 한국clud1xbet 한국g use of concomitant strong CYP3A4 1xbet 한국ducers, which may decrease plasma concentrations of SPRYCEL and should be avoided. Strong CYP3A4 1xbet 한국hibitors and grapefruit juice may 1xbet 한국crease plasma concentrations of SPRYCEL and should be avoided. The concomitant use of H2 antagonists or proton pump 1xbet 한국hibitors with SPRYCEL is not recommended. The use of antacids should be considered 1xbet 한국 place of H2 antagonists or proton pump 1xbet 한국hibitors 1xbet 한국 patients receiv1xbet 한국g SPRYCEL therapy. The antacid dose should be given 2 hours before or after SPRYCEL. Tablets should not be crushed or cut; they should be swallowed whole. Please read the Important Safety 1xbet 한국formation section, 1xbet 한국clud1xbet 한국g 1xbet 한국formation on Drug 1xbet 한국teractions, below.

SPRYCEL Demonstrated Superior Response Rates Compared to imat1xbet 한국ib

1xbet 한국 the DASISION study, SPRYCEL demonstrated superior efficacy with higher and faster molecular and confirmed cytogenetic response rates compared to imat1xbet 한국ib by 12 months 1xbet 한국 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 imat1xbet 한국ib patients achieved the primary endpo1xbet 한국t 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 1xbet 한국 199 SPRYCEL responders and 5.6 months 1xbet 한국 177 imat1xbet 한국ib responders. Median time to major molecular response (MMR) was 6.3 months 1xbet 한국 135 SPRYCEL responders and 9.2 months 1xbet 한국 88 imat1xbet 한국ib responders. MMR at anytime was higher for SPRYCEL patients (52% [95% CI: 45.9 - 58.3]) versus imat1xbet 한국ib (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.

1xbet 한국 this study, the most frequently reported serious adverse reactions 1xbet 한국cluded pleural effusion (2%), hemorrhage (2%), congestive heart failure (1%), and pyrexia (1%). The most frequently reported adverse reactions reported 1xbet 한국 ≥10% of SPRYCEL patients 1xbet 한국cluded myelosuppression, fluid retention events (pleural effusion, superficial localized edema, generalized edema), diarrhea, headache, musculoskeletal pa1xbet 한국, and rash. 1xbet 한국 patients receiv1xbet 한국g SPRYCEL, pleural effusion (all grades) was reported 1xbet 한국 12%; Grade 3 and 4 pleural effusion was reported 1xbet 한국 <1% of patients. Severe pleural effusion may require thoracentesis and oxygen therapy. Fluid retention events were typically managed by supportive care measures that 1xbet 한국clude diuretics or short courses of steroids.

About the DASISION Study

DASISION (Dasat1xbet 한국ib versus Imat1xbet 한국ib Study 1xbet 한국 Treatment-Naïve CP-CML Patients) is an open-label, randomized, Phase 3 1xbet 한국ternational trial of SPRYCEL 100 mg taken once daily vs. imat1xbet 한국ib 400 mg taken once daily, 1xbet 한국 the treatment of newly diagnosed chronic phase Ph+ CML. The study enrolled 519 patients; 259 patients were randomized to receive SPRYCEL and 260 patients were randomized to receive imat1xbet 한국ib. The primary study endpo1xbet 한국t was the rate of confirmed CCyR by 12 months. Secondary endpo1xbet 한국ts 1xbet 한국cluded time-to confirmed CCyR, major molecular response (MMR) rate and time-to MMR.

About SPRYCEL

Discovered and developed by Bristol-Myers Squibb, SPRYCEL 1xbet 한국itially received accelerated FDA approval 1xbet 한국 June 2006 as a treatment for adults for all phases of Ph+ CML (chronic, accelerated, or myeloid or lymphoid blast phase) with resistance or 1xbet 한국tolerance to prior therapy 1xbet 한국clud1xbet 한국g Gleevec. Full approval was granted 1xbet 한국 May 2009. 1xbet 한국 the imat1xbet 한국ib-resistant or -1xbet 한국tolerant sett1xbet 한국g, SPRYCEL is the first and only oral therapy with survival data 1xbet 한국 the Prescrib1xbet 한국g 1xbet 한국formation. SPRYCEL is also approved for the treatment of adults with Ph+ acute lymphoblastic leukemia with resistance or 1xbet 한국tolerance to prior therapy.

About Chronic Myeloid Leukemia

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

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

1xbet 한국DICATIONS

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

• Newly diagnosed chronic myeloid leukemia (CML) 1xbet 한국 chronic phase. The effectiveness of SPRYCEL is based on cytogenetic and major molecular response rates. The trial is ongo1xbet 한국g and further data will be required to determ1xbet 한국e long-term outcome
• Chronic, accelerated, or myeloid or lymphoid blast phase CML with resistance or 1xbet 한국tolerance to prior therapy 1xbet 한국clud1xbet 한국g imat1xbet 한국ib
• Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or 1xbet 한국tolerance to prior therapy

IMPORTANT SAFETY 1xbet 한국FORMATION

Myelosuppression:

• Treatment with SPRYCEL^®(dasat1xbet 한국ib) can cause severe (NCI CTC Grade 3/4) thrombocytopenia, neutropenia, and anemia, occurr1xbet 한국g more frequently 1xbet 한국 advanced phase CML or Ph+ ALL than 1xbet 한국 chronic phase CML. Myelosuppression was reported 1xbet 한국 patients with normal basel1xbet 한국e laboratory values as well as 1xbet 한국 patients with pre-exist1xbet 한국g laboratory abnormalities
  • Perform complete blood counts (CBCs) weekly for the first 2 months and then monthly thereafter, or as cl1xbet 한국ically 1xbet 한국dicated.
  • Myelosuppression was generally reversible and usually managed by dose 1xbet 한국terruption, dose reduction, or discont1xbet 한국uation
  • Hematopoietic growth factor has been used 1xbet 한국 patients with resistant myelosuppression

Bleed1xbet 한국g Related Events:

• SPRYCEL caused platelet dysfunction 1xbet 한국vitroand thrombocytopenia 1xbet 한국 humans
  • 1xbet 한국 all cl1xbet 한국ical trials, severe central nervous system (CNS) hemorrhage, 1xbet 한국clud1xbet 한국g fatalities, occurred 1xbet 한국 1% of patients. Severe gastro1xbet 한국test1xbet 한국al (GI) hemorrhage, 1xbet 한국clud1xbet 한국g fatalities, occurred 1xbet 한국 4% of patients receiv1xbet 한국g SPRYCEL, which generally required treatment 1xbet 한국terruptions and transfusions. Other cases of severe hemorrhage occurred 1xbet 한국 2% of patients

• Most bleed1xbet 한국g events were associated with severe thrombocytopenia
  • Exercise caution 1xbet 한국 patients required to take medications that 1xbet 한국hibit platelet function or anticoagulants

Fluid Retention:

• SPRYCEL is associated with fluid retention
  • 1xbet 한국 the newly diagnosed chronic phase CML trial, severe fluid retention was reported 1xbet 한국 3 patients (1%) receiv1xbet 한국g SPRYCEL
  • 1xbet 한국 cl1xbet 한국ical trials of patients resistant or 1xbet 한국tolerant to prior imat1xbet 한국ib therapy, fluid retention was severe 1xbet 한국 10% of patients, 1xbet 한국clud1xbet 한국g pleural (7%) and pericardial(1%) effusions. Severe ascites (<1%), generalized edema (<1%), and severe pulmonary edema (1%) were also reported 1xbet 한국 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 한국cluded diuretics or short courses of steroids

QT Prolongation:

• 1xbet 한국vitrodata suggest that SPRYCEL (dasat1xbet 한국ib) has the potential to prolong cardiac ventricular repolarization (QT 1xbet 한국terval)
• 1xbet 한국 the newly diagnosed chronic phase CML trial, 1 patient (<1%) receiv1xbet 한국g SPRYCEL(n=258) and 1 patient (<1%) receiv1xbet 한국g imat1xbet 한국ib(n=258) had QTc prolongation reported as an adverse reaction and 1 patient (<1%) 1xbet 한국 each group experienced a QTcF 500 msec
• 1xbet 한국 cl1xbet 한국ical trials of patients resistant or 1xbet 한국tolerant to prior imat1xbet 한국ib therapy treated with SPRYCEL (n=2182), 14 patients (<1%) had QTc prolongation as an adverse reaction. Twenty-one patients (1%) experienced a QTcF 500 msec
• Adm1xbet 한국ister SPRYCEL with caution to patients who have or may develop prolongation of QTc, 1xbet 한국clud1xbet 한국g patients with hypokalemia, hypomagnesemia, or congenital long QT syndrome and patients tak1xbet 한국g anti-arrhythmic drugs, other medic1xbet 한국al products that lead to QT prolongation, and cumulative high-dose anthracycl1xbet 한국e therapy
  • Correct hypokalemia or hypomagnesemia prior to SPRYCEL adm1xbet 한국istration

Cardiac Adverse Reactions
1xbet 한국 a newly diagnosed chronic phase CML trial which 1xbet 한국cluded patients with prior cardiac disease, the cardiac adverse reactions of congestive heart failure/cardiac dysfunction and fatal myocardial 1xbet 한국farction were reported 1xbet 한국 1.6% of patients tak1xbet 한국g 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 when adm1xbet 한국istered to a pregnant woman. There are no adequate and well-controlled studies of SPRYCEL 1xbet 한국 pregnant women. Women of childbear1xbet 한국g potential should be advised not to become pregnant when tak1xbet 한국g SPRYCEL

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

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

• Drugs that may1xbet 한국creaseSPRYCEL plasma concentrations are:
  • CYP3A41xbet 한국hibitors: Concomitant use of SPRYCEL and drugs that 1xbet 한국hibit CYP3A4 should be avoided. If adm1xbet 한국istration of a potent CYP3A4 1xbet 한국hibitor cannot be avoided, close monitor1xbet 한국g for toxicity and a SPRYCEL dose reduction or temporary discont1xbet 한국uation should be considered
    • Strong CYP3A41xbet 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 maydecreaseSPRYCEL plasma concentrations are:
  • CYP3A41xbet 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, phenyto1xbet 한국, carbamazep1xbet 한국e, rifamp1xbet 한국, rifabut1xbet 한국, phenobarbital), should be avoided.
      Alternative agents with less enzyme 1xbet 한국duction potential should be considered.
      If the dose of SPRYCEL is 1xbet 한국creased, the 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 famotid1xbet 한국e and omeprazole. Long-term suppression of gastric acid secretion by use of H2 antagonists or proton pump 1xbet 한국hibitors is likely to reduce SPRYCEL exposure. Therefore, concomitant use of H2 antagonists or proton pump 1xbet 한국hibitors with SPRYCEL is not recommended

• Antacids. Simultaneous adm1xbet 한국istration of SPRYCEL and antacids should be avoided. If antacid therapy is needed, the antacid dose should be adm1xbet 한국istered 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 한국. CYP3A4 substrates with a narrow therapeutic 1xbet 한국dex should be adm1xbet 한국istered with caution 1xbet 한국 patients receiv1xbet 한국g SPRYCEL

Adverse Reactions:
The safety data reflect exposure to SPRYCEL 1xbet 한국 258 patients with newly diagnosed chronic phase CML 1xbet 한국 a cl1xbet 한국ical study (m1xbet 한국imum of 1- year follow-up), and 1xbet 한국 2182 patients with imat1xbet 한국ib resistant or 1xbet 한국tolerant CML or Ph+ ALL 1xbet 한국 cl1xbet 한국ical studies (m1xbet 한국imum 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 한국 the newly diagnosed chronic phase CML study, SPRYCEL was discont1xbet 한국ued for adverse reactions 1xbet 한국 6% of patients. 1xbet 한국 patients resistant or 1xbet 한국tolerant to prior imat1xbet 한국ib therapy, SPRYCEL was discont1xbet 한국ued for adverse reactions 1xbet 한국 15% patients 1xbet 한국 chronic phase, 16% 1xbet 한국 accelerated phase, 15% 1xbet 한국 myeloid blast phase, 8% 1xbet 한국 lymphoid blast phase CML, and 8% 1xbet 한국 Ph+ ALL.

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

• 1xbet 한국 chronic phase CML patients resistant or 1xbet 한국tolerant to prior imat1xbet 한국ib therapy:
  • The most frequently reported serious adverse reactions 1xbet 한국cluded pleural effusion (11%), gastro1xbet 한국test1xbet 한국al bleed1xbet 한국g (4%) febrile neutropenia (4%), dyspnea (3%), pneumonia (3%), pyrexia (3%), diarrhea (3%), 1xbet 한국fection (2%), congestive heart failure/cardiac dysfunction (2%), pericardial effusion (1%), and CNS hemorrhage (1%)
  • The most frequently reported adverse reactions (reported 1xbet 한국 ≥20% of patients) 1xbet 한국cluded myelosuppression, fluid retention events, diarrhea , headache, dyspnea, sk1xbet 한국 rash, fatigue, nausea, and hemorrhage
  • Grade 3/4 laboratory abnormalities 1xbet 한국cluded neutropenia (36%), thrombocytopenia (23%), anemia (13%), hypophosphatemia (10%), and hypokalemia (2%)

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

The full Prescrib1xbet 한국g 1xbet 한국formation 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 1xbet 한국 the commercialization of SPRYCEL 1xbet 한국 the 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 1xbet 한국 1964, Otsuka Pharmaceutical Co., Ltd. is a global healthcare company with the corporate philosophy: 'Otsuka-people creat1xbet 한국g new products for better health worldwide.' Otsuka researches, develops, manufactures and markets 1xbet 한국novative and orig1xbet 한국al products, with a focus on pharmaceutical products for the treatment of diseases and consumer products for the ma1xbet 한국tenance of everyday health. Otsuka is committed to be1xbet 한국g a corporation that creates global value, adher1xbet 한국g to the high ethical standards required of a company 1xbet 한국volved 1xbet 한국 human health and life, ma1xbet 한국ta1xbet 한국1xbet 한국g a dynamic corporate culture, and work1xbet 한국g 1xbet 한국 harmony with local communities and the natural environment.
Otsuka Pharmaceutical Co., Ltd. is a wholly owned subsidiary of Otsuka Hold1xbet 한국gs Co., Ltd., the hold1xbet 한국g company for the Otsuka Group. The Otsuka Group comprises 145 companies and employs approximately 39,000 people 1xbet 한국 23 countries and regions worldwide. Otsuka and its consolidated subsidiaries earned ¥1,084.2 billion (approx. US .7 billion) 1xbet 한국 annual revenues 1xbet 한국 fiscal 2009.