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SUMMIT, N.J.--( / ) June 08, 2016 -- Celgene Corporation (NASDAQ:CELG) today announced data from a meta-analysis of overall survival in multiple myeloma (MM) patients receiving investigational maintenance treatment with REVLIMID® (lenalidomide) capsules following high-dose melphalan and autologous stem cell transplant (ASCT) were presented during the 52nd ASCO Annual Meeting in Chicago, Illinois. The analysis, based on data from studies conducted by the Alliance for Clinical Trials in Oncology (formerly Cancer and Leukemia Group B) with support from the National Cancer Institute, Intergroupe Francophone du Myelome (IFM) and the Gruppo Italiano Malattie EMatologiche dell’Adulto (GIMEMA), was presented by Dr. Philip McCarthy of Roswell Park Cancer Institute and lead investigator of the CALGB (Alliance) 100104 study. The findings demonstrated significantly prolonged overall survival (OS) compared to the control arm of placebo or no maintenance.
A meta-analysis of patient-level data from 1,209 patients in three randomized, controlled phase III studies (CALGB (Alliance) 100104, IFM 2005-02, GIMEMA-RVMM-PI-209) was conducted comparing lenalidomide maintenance (n=605) to either placebo or no maintenance (n=604). Each of these studies had individually shown that investigational lenalidomide maintenance treatment following autologous stem cell transplant reduced the risk of disease progression or death (PFS), the primary endpoint, by approximately 50% (McCarthy NEJM 2012; Attal NEJM 2012; Palumbo NEJM 2014).
Results of this analysis showed that at a median follow-up of 80 months, the median overall survival had not been reached for patients receiving lenalidomide maintenance compared with 86 months for the control arm [95% CI: HR 0.74 (0.62-0.89); p=0.001], representing an estimated 2.5-year benefit in favor of lenalidomide maintenance. Hazard ratios for each of the three studies favored maintenance treatment with lenalidomide. While not individually powered to evaluate this endpoint, each study contributed to the pooled OS benefit observed in the meta-analysis.
The risk of developing a hematologic second primary malignancy (SPM) in the lenalidomide arm in the pooled analysis had a hazard ratio of 2.03 (95% CI: 1.14-3.61). The risk of developing a solid tumor SPM in the lenalidomide arm had a hazard ratio of 1.71 (95% CI: 1.04-2.79). Hematologic SPMs observed in the studies totaled 15 for the lenalidomide arm and eight for the control arm in CALGB (Alliance) 100104, 21 for lenalidomide and nine for control in IFM 2005-02, and none for either arm in the GIMEMA-RVMM-PI-209 study. Solid tumor SPMs observed in the studies totaled 17 for the lenalidomide arm and 10 for the control arm in CALGB (Alliance) 100104, 21 for lenalidomide and 13 for control in IFM 2005-02, and five for lenalidomide and two for the control arm in the GIMEMA-RVMM-PI-209 study.
“The results of this meta-analysis reinforce the long-term benefit that lenalidomide maintenance therapy has demonstrated in myeloma patients who receive an autologous stem cell transplant within the large, phase III studies individually,” said Dr. Antonio Palumbo of the University of Torino and the lead investigator of the GIMEMA study.
“Lenalidomide has consistently demonstrated improvement in progression-free survival in this setting,” said Prof. Michel Attal of the University of Toulouse and the lead investigator of the IFM study. “The improved overall survival shown by this meta-analysis further supports the positive benefit-risk ratio observed in the individual phase III studies.”
REVLIMID is not indicated for maintenance treatment following ASCT.
About the studies
CALGB (Alliance) 100104
The study is a phase III, multicenter, randomized, double-blind, placebo-controlled trial in the first-line setting of MM that was conducted at 47 centers in the U.S. The study was sponsored and conducted by the CALGB, which is now part of the Alliance for Clinical Trials in Oncology, a U.S. national oncology cooperative group. The primary objective was to determine if maintenance treatment with lenalidomide would prolong time to tumor progression. Subjects were registered after completion of induction therapy and before ASCT. The starting dosage of lenalidomide was 10 mg/day (to be increased to 15 mg/day after three months for subjects who tolerated maintenance therapy).
IFM 2005-02
This study is a phase III, multicenter, randomized, double-blind, placebo-controlled trial that was conducted in the first-line setting of MM by the IFM, an independent French myeloma cooperative group, at 78 centers in France, Belgium and Switzerland. The primary objective of the IFM study was to evaluate the efficacy of maintenance treatment with lenalidomide following ASCT in extending post-transplant PFS, the primary endpoint. Subjects underwent induction chemotherapy and ASCT before inclusion in the study.
Patients were randomly assigned in a 1:1 ratio to receive either consolidation treatment with lenalidomide (at a dose of 25 mg/day, on days 1 to 21 of each 28-day cycle, for two cycles), followed by maintenance therapy with lenalidomide at a starting dose of 10 mg/day (to be increased up to 15 mg/day after three months in absence of dose-limiting toxicity), or the same consolidation treatment with lenalidomide, followed by maintenance therapy with placebo.
GIMEMA-RVMM-PI-209
This study is a phase III, multicenter, open-label, 2 x 2 factorial, controlled study conducted by Fondazione Neoplasie Sangue Onlus (FO.NE.SA Onlus), an independent Italian cooperative group, in the first-line setting of transplant-eligible newly diagnosed MM (NDMM). The study was conducted at 62 centers in Italy and Israel. The primary objective was to determine (after induction treatment with a standard Rd regimen) the efficacy and safety of treatment with melphalan, prednisone, REVLIMID versus high-dose melphalan (200 mg/m2) followed by ASCT in NDMM subjects in extending PFS, the primary endpoint. As a secondary objective, the efficacy and safety of lenalidomide as maintenance treatment were evaluated.
About REVLIMID®
REVLIMID® (lenalidomide) in combination with dexamethasone (dex) is indicated for the treatment of patients with multiple myeloma (MM)
REVLIMID is not indicated and is not recommended for the treatment of patients with chronic lymphocytic leukemia (CLL) outside of controlled clinical trials
Important Safety Information
WARNING: EMBRYO-FETAL TOXICITY, HEMATOLOGIC TOXICITY, and VENOUS and ARTERIAL THROMBOEMBOLISM
Embryo-Fetal Toxicity
Do not use REVLIMID during pregnancy. Lenalidomide, a thalidomide analogue, caused limb abnormalities in a developmental monkey study. Thalidomide is a known human teratogen that causes severe life-threatening human birth defects. If lenalidomide is used during pregnancy, it may cause birth defects or embryo-fetal death. In females of reproductive potential, obtain 2 negative pregnancy tests before starting REVLIMID treatment. Females of reproductive potential must use 2 forms of contraception or continuously abstain from heterosexual sex during and for 4 weeks after REVLIMID treatment. To avoid embryo-fetal exposure to lenalidomide, REVLIMID is only available through a restricted distribution program, the REVLIMID REMS® program (formerly known as the “RevAssist®” program).
Information about the REVLIMID REMS® program is available at or by calling the manufacturer’s toll-free number 1-888-423-5436.
Hematologic Toxicity (Neutropenia and Thrombocytopenia)
REVLIMID can cause significant neutropenia and thrombocytopenia. Eighty percent of patients with del 5q MDS had to have a dose delay/reduction during the major study. Thirty-four percent of patients had to have a second dose delay/reduction. Grade 3 or 4 hematologic toxicity was seen in 80% of patients enrolled in the study. Patients on therapy for del 5q MDS should have their complete blood counts monitored weekly for the first 8 weeks of therapy and at least monthly thereafter. Patients may require dose interruption and/or reduction. Patients may require use of blood product support and/or growth factors.
Venous and Arterial Thromboembolism
REVLIMID has demonstrated a significantly increased risk of deep vein thrombosis (DVT) and pulmonary embolism (PE), as well as risk of myocardial infarction and stroke in patients with MM who were treated with REVLIMID and dexamethasone therapy. Monitor for and advise patients about signs and symptoms of thromboembolism. Advise patients to seek immediate medical care if they develop symptoms such as shortness of breath, chest pain, or arm or leg swelling. Thromboprophylaxis is recommended and the choice of regimen should be based on an assessment of the patient’s underlying risks.
CONTRAINDICATIONS
Pregnancy: REVLIMID can cause fetal harm when administered to a pregnant female and is contraindicated in females who are pregnant. If this drug is used during pregnancy or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus
Allergic Reactions: REVLIMID is contraindicated in patients who have demonstrated hypersensitivity (e.g., angioedema, Stevens-Johnson syndrome, toxic epidermal necrolysis) to lenalidomide
WARNINGS AND PRECAUTIONS
Embryo-Fetal Toxicity: See Boxed WARNINGS
· Females of Reproductive Potential: See Boxed WARNINGS
· Males: Lenalidomide is present in the semen of patients receiving the drug. Males must always use a latex or synthetic condom during any sexual contact with females of reproductive potential while taking REVLIMID and for up to 28 days after discontinuing REVLIMID, even if they have undergone a successful vasectomy. Male patients taking REVLIMID must not donate sperm
· Blood Donation: Patients must not donate blood during treatment with REVLIMID and for 1 month following discontinuation of the drug because the blood might be given to a pregnant female patient whose fetus must not be exposed to REVLIMID
REVLIMID REMS® Program: See Boxed WARNINGS: Prescribers and pharmacies must be certified with the REVLIMID REMS program by enrolling and complying with the REMS requirements; pharmacies must only dispense to patients who are authorized to receive REVLIMID. Patients must sign a Patient-Physician Agreement Form and comply with REMS requirements; female patients of reproductive potential who are not pregnant must comply with the pregnancy testing and contraception requirements and males must comply with contraception requirements
Hematologic Toxicity: REVLIMID can cause significant neutropenia and thrombocytopenia. Monitor patients with neutropenia for signs of infection. Advise patients to observe for bleeding or bruising, especially with use of concomitant medications that may increase risk of bleeding. MM: Patients taking REVLIMID/dex should have their complete blood counts (CBC) assessed every 7 days for the first 2 cycles, on days 1 and 15 of cycle 3, and every 28 days thereafter
Venous and Arterial Thromboembolism: See Boxed WARNINGS: Venous thromboembolic events (DVT and PE) and arterial thromboses (MI and CVA) are increased in patients treated with REVLIMID. Patients with known risk factors, including prior thrombosis, may be at greater risk and actions should be taken to try to minimize all modifiable factors (e.g., hyperlipidemia, hypertension, smoking). Thromboprophylaxis is recommended and regimen is based on patients underlying risks. ESAs and estrogens may further increase the risk of thrombosis and their use should be based on a benefit-risk decision
Increased Mortality in Patients With CLL: In a clinical trial in the first line treatment of patients with CLL, single agent REVLIMID therapy increased the risk of death as compared to single agent chlorambucil. Serious adverse cardiovascular reactions, including atrial fibrillation, myocardial infarction, and cardiac failure, occurred more frequently in the REVLIMID arm. REVLIMID is not indicated and not recommended for use in CLL outside of controlled clinical trials
Second Primary Malignancies (SPM): In clinical trials in patients with MM receiving REVLIMID, an increase of invasive SPM notably AML and MDS have been observed. Monitor patients for the development of SPMs. Take into account both the potential benefit of REVLIMID and risk of SPMs when considering treatment
Hepatotoxicity: Hepatic failure, including fatal cases, has occurred in patients treated with REVLIMID/dex. Pre-existing viral liver disease, elevated baseline liver enzymes, and concomitant medications may be risk factors. Monitor liver enzymes periodically. Stop REVLIMID upon elevation of liver enzymes. After return to baseline values, treatment at a lower dose may be considered
Allergic Reactions: Angioedema and serious dermatologic reactions including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) have been reported. These events can be fatal. Patients with a prior history of Grade 4 rash associated with thalidomide treatment should not receive REVLIMID. REVLIMID interruption or discontinuation should be considered for Grade 2-3 skin rash. REVLIMID must be discontinued for angioedema, Grade 4 rash, exfoliative or bullous rash, or if SJS or TEN is suspected and should not be resumed following discontinuation for these reactions. REVLIMID capsules contain lactose; risk-benefit of treatment should be evaluated in patients with lactose intolerance
Tumor Lysis Syndrome (TLS): Fatal instances of TLS have been reported during treatment with lenalidomide. The patients at risk of TLS are those with high tumor burden prior to treatment. These patients should be monitored closely and appropriate precautions taken
Tumor Flare Reaction (TFR): TFR has occurred during investigational use of lenalidomide for CLL and lymphoma. Monitoring and evaluation of TFR is recommended in patients with MCL. Tumor flare may mimic the progression of disease (PD). In patients with Grade 3 or 4 TFR, it is recommended to withhold treatment with REVLIMID until TFR resolves to ≤ Grade 1. REVLIMID may be continued in patients with Grade 1 and 2 TFR without interruption or modification, at the physician’s discretion
Impaired Stem Cell Mobilization: A decrease in the number of CD34+ cells collected after treatment (> 4 cycles) with REVLIMID has been reported. Consider early referral to transplant center to optimize timing of the stem cell collection
ADVERSE REACTIONS
Multiple Myeloma
· In newly diagnosed: The most frequently reported Grade 3 or 4 reactions included neutropenia, anemia, thrombocytopenia, pneumonia, asthenia, fatigue, back pain, hypokalemia, rash, cataract, lymphopenia, dyspnea, DVT, hyperglycemia, and leukopenia. The highest frequency of infections occurred in Arm Rd Continuous (75%) compared to Arm MPT (56%). There were more grade 3 and 4 and serious adverse reactions of infection in Arm Rd Continuous than either Arm MPT or RD18
· The most common adverse reactions reported in ≥20% (Arm Rd Continuous): diarrhea (46%), anemia (44%), neutropenia (35%), fatigue (33%), back pain (32%), asthenia (28%), insomnia (28%), rash, (26%), decreased appetite (23%), cough (23%), dyspnea (22%), pyrexia (21%), abdominal pain (21%), muscle spasms (20%), and thrombocytopenia (20%)
· After at least one prior therapy the most common adverse reactions reported in ≥20% (REVLIMID/dex vs dex/placebo): fatigue (44% vs 42%), neutropenia (42% vs 6%), constipation (41% vs 21%), diarrhea (39% vs 27%), muscle cramp (33% vs 21%), anemia (31% vs 24%), pyrexia (28% vs 23%), peripheral edema (26% vs 21%), nausea (26% vs 21%), back pain (26% vs 19%), upper respiratory tract infection (25% vs 16%), dyspnea (24% vs 17%), dizziness (23% vs 17%), thrombocytopenia (22% vs 11%), rash (21% vs 9%), tremor (21% vs 7%), and weight decreased (20% vs 15%)
DRUG INTERACTIONS
Periodic monitoring of digoxin plasma levels is recommended due to increased Cmax and AUC with concomitant REVLIMID therapy. Patients taking concomitant therapies such as erythropoietin stimulating agents or estrogen containing therapies may have an increased risk of thrombosis. It is not known whether there is an interaction between dex and warfarin. Close monitoring of PT and INR is recommended in MM patients taking concomitant warfarin
NURSING MOTHERS
Discontinue drug or nursing taking into consideration the importance of the drug to the mother
PEDIATRIC USE
Safety and effectiveness in patients below the age of 18 have not been established
RENAL IMPAIRMENT
REVLIMID is primarily excreted unchanged by the kidneys; adjustments to the starting dose are recommended to provide appropriate drug exposure in patients with moderate or severe renal impairment and in patients on dialysis
Please see accompanying full Prescribing Information, including Boxed WARNINGS.
About Celgene
Celgene Corporation, headquartered in Summit, New Jersey, is an integrated global biopharmaceutical company engaged primarily in the discovery, development and commercialization of innovative therapies for the treatment of cancer and inflammatory diseases through next-generation solutions in protein homeostasis, immuno-oncology, epigenetics, immunology and neuro-inflammation. For more information, please visit Follow Celgene on Social Media: @Celgene, Pinterest, LinkedIn, FaceBook and YouTube.
Forward-Looking Statements
This press release may contain forward-looking statements, which are generally statements that are not historical facts. Forward-looking statements can be identified by the words “expects,” “anticipates,” “believes,” “intends,” “estimates,” “plans,” “will,” “outlook” and similar expressions. Forward-looking statements are based on management's current plans, estimates, assumptions and projections, and speak only as of the date they are made. We undertake no obligation to update any forward-looking statement in light of new information or future events, except as otherwise required by law. Forward-looking statements involve inherent risks and uncertainties, most of which are difficult to predict and are generally beyond our control. Actual results or outcomes may differ materially from those implied by the forward-looking statements as a result of the impact of a number of factors, many of which are discussed in more detail in our Annual Report on Form 10-K and other reports filed with the Securities and Exchange Commission.
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TOKYO & LIMBURGERHOF, GERMANY--( / ) 둔촌동홀덤카페 December 07, 2017 -- WOW Mitsui Chemicals 둔촌동홀덤카페 오키타안리 Agro, Inc. (MCAG) and BASF SE announced today the signing of a long-term agreement for the commercialization of Broflanilide, a new WOW 키타미카나미 insecticide 성인19 TOKYOchewing crop pests and non-crop pests control. This 둔촌동홀덤카페 하네다아이 commercialization agreement follows the exclusive global license and development agreement between the two companies that was announced on June 11, 2014.
Under the terms of 둔촌동홀덤카페 황가희 this 둔촌동홀덤카페 중국길거리성추행 agreement, MCAG granted BASF exclusive rights to WOW 고딩착한글래머 market and sell Broflanilide products in certain markets worldwide, excluding Japan and certain 실버남근사용후기 Under둔촌동홀덤카페 원샷홀덤 유두흡착기수입 Underother countries where FETISH Underholds exclusive and/or co-exclusive rights.
Broflanilide is a compound with a novel mode of action, demonstrating excellent efficacy in WOW the control of many problematic chewing insect pests, 조이티비 Broflanilidecaterpillars and beetles WOW 모델최은정 in specialty and row crops, and non-crop pests such as termites, ants, cockroaches and flies. 둔촌동홀덤카페 It has potential use applications in cereals as a seed treatment for control of wireworms, as well as WOW 박다솜 for foliar use in leafy and fruiting vegetables, potato, 남산면홀덤 Broflanilidecotton, corn and legumes. The active ingredient was discovered by MCAG and the co-development of the 둔촌동홀덤카페 홀덤승률 insecticide with BASF began in 2014.
The Insecticide 둔촌동홀덤카페 텍사스홀덤추천 Resistance Action Committee (IRAC) recently approved the classification of Broflanilide as a compound WOW 베트맨 with a new mode of action in 둔촌동홀덤카페 제니하우스볼륨팡팡 Group 30: 둔촌동홀덤카페 토토하는법 GABA-gated Cl- channel allosteric modulators. As of today, Broflanilide is the only active ingredient in IRAC Group 30. Given its different chemistry, Broflanilide is a yOVohNR Theeffective broad-use compound and a 원천동고스톱 Thenew tool in Insecticide Resistance Management (IRM).
“We’re excited 둔촌동홀덤카페 사설사이트 to continue leveraging the expertise and 암사동홀덤카페 “We’reof each company to offer promising innovative solutions to growers 봉익동홀덤대회 “We’repest management professionals seeking alternatives to existing pest-targeting chemistries,” 둔촌동홀덤카페 WOW said Jurgen Huff, Senior Vice President Global Strategic Marketing, BASF Crop Protection.
“We are also confident that Broflanilide products, with their 성인무료 “Weperformance and novel mode of action, can contribute to those in both agriculture and professional 둔촌동홀덤카페 롤토토 WOW 롤토토 pest management seeking effective solutions,” said Shoichi Kondo, Head 일본야한만화 “WeMCAG's International Business Division. “This collaboration will contribute 한영희 “Weour future growth.” WOW
First market 자브넷 Firstof Broflanilide products are expected in WOW 사설배팅 2020. The financial terms 둔촌동홀덤카페 축구해외배당흐름 of this agreement were not disclosed.
야피스 AboutMitsui 둔촌동홀덤카페 사설토토사이트 WOW 사설토토사이트 생중계카지노 AboutGroup WOW 사커라인토토
Mitsui Chemicals (TOKYO: 4183) (ISIN: JP3888300005), which WOW 신세경가슴골 traces its roots back to 1912, has an annual sale of 1,200 billion yen in the fiscal year ending 올스포츠 Mitsui2017 and more than 130 companies with over 13,000 employees in 28 countries. As one of Japan’s leading chemical 둔촌동홀덤카페 SICKJUNK MitsuiMitsui Chemicals contributes broadly to society by providing high-quality products and services to customers through innovations and creation of materials and products while keeping in harmony with the global environment. Its business portfolio includes materials for next-generation mobility, healthcare services, packaging, agrochemicals, electronic materials, and environment and energy sector. Mitsui Chemicals will continue to contribute to solving social challenges with its state-of-the-art technology and by “Creating New Customer Value through Innovation”. Mitsui Chemicals’ global agrochemical business is operated by its 100% subsidiary, Mitsui Chemicals Agro, Inc., who supplies innovative agrochemicals for crop protection and pest management. With a customer-centric point of view, The Company offers unique and effective products and services, and contributes to the sustainable, productive agriculture. Latest group news can be found at
네오샵 About둔촌동홀덤카페 서인영노출 BASF’s WOW 축구일정 Crop WOW 노출 Aboutdivision 둔촌동홀덤카페 축구중계사이트
With WOW a rapidly growing population, the world is increasingly dependent on our ability to develop and maintain 둔촌동홀덤카페 축구분석사이트 sustainable agriculture and healthy environments. BASF’s Crop Protection division works with farmers, agricultural professionals, 노출 Withmanagement experts and others to help make this possible. With their cooperation, BASF is able to sustain an active R&D pipeline, an innovative portfolio of products and services, and teams of 둔촌동홀덤카페 experts in the lab and in the field to support customers in making their businesses succeed. In 2016, BASF’s Crop Protection division generated sales of €5.6 billion. For more information, please visit us at or on any of our social media channels.
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