Navigation Links
Thalidomide Pharmion(R) Receives Positive Opinion for Treatment of First-line Multiple Myeloma from European Medicines Agency
Date:1/24/2008

g and complex process and I would like to thank all of the participants in the dialogue that has led to this recommendation by the EMEA, which include European thalidomide groups, patient organizations, the hematology community and the employees of Pharmion who made this happen. We have been and will remain committed to managing Thalidomide with the respect that its history requires."

The Marketing Authorization Application reviewed by the EMEA is based upon a clinical data package comprised of studies of nearly 1400 patients in total, including the Intergroupe Francophone du Myelome (IFM) 99-06 survival study. The three-arm study conducted by IFM demonstrated the superiority of melphalan/prednisone plus Thalidomide (MPT) over standard therapy of melphalan/prednisone (MP) or a combination of chemotherapies (vincristine/adriamycin/dexamethasone (VAD)) followed by melphalan and transplantation (MEL 100) in the treatment of newly diagnosed multiple myeloma patients, aged 65 to 75 who were ineligible for intensive bone marrow transplantation. A total of 447 patients were randomized to one of the three treatment arms. At final analysis, the overall median survival in the MPT arm was 51.6 months, compared to 33.2 and 38.3 months, respectively, for the MP and MEL 100 arms. The hazard ratios were 0.59 and 0.69, respectively. Thalidomide treatment was generally well-tolerated by the majority of patients. The most frequently reported adverse events associated with MPT included neutropenia, somnolence and constipation. The Thalidomide combination was also associated with a 5-10% greater risk of Grade 3 and 4 venous thromboembolism and peripheral neuropathy.

"Our study results demonstrate the profound impact on overall survival that the addition of Thalidomide to the standard of care can provide to patients with untreated multiple myeloma," said Professor Philippe Moreau, Professor of Clinical Hematology at Nantes Faculty of Medicine and Chairman of the Intergroup
'/>"/>

SOURCE Pharmion Corporation
Copyright©2008 PR Newswire.
All rights reserved

Page: 1 2 3 4 5 6

Related medicine technology :

1. Peregrine Pharmaceuticals Receives Approval to Conduct a Second Phase II Trial of Bavituximab in Patients With Advanced Breast Cancer
2. Photo: Welchol(TM) (colesevelam HCl) Receives FDA Approval to Reduce Blood Glucose in Adults with Type 2 Diabetes
3. Peregrine Pharmaceuticals Receives Approval to Conduct a Phase II Trial of Bavituximab in Patients With Non-Small Cell Lung Cancer
4. Abbotts HUMIRA(R) (adalimumab) Receives FDA Approval For Moderate to Severe Chronic Plaque Psoriasis
5. Vical Receives Payment from AnGes MG for Allovectin-7(R) Phase 3 Pivotal Trial
6. Fovea Pharmaceuticals Receives Orphan Drug Designation from EC for RdCVF for the Treatment of Retinitis Pigmentosa
7. Hawaii Biotech Receives Allowance to Perform West Nile Vaccine Clinical Trials
8. Celldex Therapeutics Receives Fast-Track Designation for CDX-110, a Novel EGFRvIII Vaccine for Glioblastoma
9. Antheras A-001 Receives Orphan Drug Status for the Prevention of Acute Chest Syndrome in Patients With Sickle Cell Disease
10. Insmed Receives FDA Orphan Drug Designation for IPLEX(TM) in the Treatment of Myotonic Muscular Dystrophy
11. Nuvelo Begins Phase 2 Trial and Receives Fast Track Status for Alfimeprase in Patients With Acute Ischemic Stroke
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:9/2/2014)... , Sept. 2, 2014 Reportlinker.com ... available in its catalogue: Acute Heart ... http://www.reportlinker.com/p0689743/Acute-Heart-Failure-Global-Clinical-Trials-Review-H2-2014.html Acute ... Summary GlobalData,s clinical trial report, ... 2014" provides data on the Acute Heart Failure ...
(Date:9/2/2014)... SANTA CLARA, Calif. , Sept. 2, 2014 /PRNewswire/ ... , is now offering a special promotion for Invisalign. ... instead of brackets and wires. It is often the ... who prefer the convenience and aesthetics of it. For ... $3,900, which is a significant savings from the usual ...
(Date:9/2/2014)... September 2, 2014 ... ESC-Kongress 2014 präsentierte GARFIELD-AF-Register bietet einen ... von schlaganfallgefährdeten Patienten in der klinischen ... Daten der nahezu 12.500 ... und unabhängigen Forschungsinitiative zur Untersuchung von ...
Breaking Medicine Technology:Acute Heart Failure Global Clinical Trials Review, H2, 2014 2Acute Heart Failure Global Clinical Trials Review, H2, 2014 3Acute Heart Failure Global Clinical Trials Review, H2, 2014 4Acute Heart Failure Global Clinical Trials Review, H2, 2014 5Acute Heart Failure Global Clinical Trials Review, H2, 2014 6Acute Heart Failure Global Clinical Trials Review, H2, 2014 7Acute Heart Failure Global Clinical Trials Review, H2, 2014 8Santa Clara Cosmetic Dentist, Dr. Alan Frame, is Now Offering a Special on Invisalign 2Daten aus dem globalen Register zur Behandlung von Vorhofflimmern zeigen, dass antithrombotische Wirkstoffe zur Verhinderung von Schlaganfällen nicht optimal genutzt werden 2Daten aus dem globalen Register zur Behandlung von Vorhofflimmern zeigen, dass antithrombotische Wirkstoffe zur Verhinderung von Schlaganfällen nicht optimal genutzt werden 3Daten aus dem globalen Register zur Behandlung von Vorhofflimmern zeigen, dass antithrombotische Wirkstoffe zur Verhinderung von Schlaganfällen nicht optimal genutzt werden 4Daten aus dem globalen Register zur Behandlung von Vorhofflimmern zeigen, dass antithrombotische Wirkstoffe zur Verhinderung von Schlaganfällen nicht optimal genutzt werden 5Daten aus dem globalen Register zur Behandlung von Vorhofflimmern zeigen, dass antithrombotische Wirkstoffe zur Verhinderung von Schlaganfällen nicht optimal genutzt werden 6Daten aus dem globalen Register zur Behandlung von Vorhofflimmern zeigen, dass antithrombotische Wirkstoffe zur Verhinderung von Schlaganfällen nicht optimal genutzt werden 7Daten aus dem globalen Register zur Behandlung von Vorhofflimmern zeigen, dass antithrombotische Wirkstoffe zur Verhinderung von Schlaganfällen nicht optimal genutzt werden 8Daten aus dem globalen Register zur Behandlung von Vorhofflimmern zeigen, dass antithrombotische Wirkstoffe zur Verhinderung von Schlaganfällen nicht optimal genutzt werden 9Daten aus dem globalen Register zur Behandlung von Vorhofflimmern zeigen, dass antithrombotische Wirkstoffe zur Verhinderung von Schlaganfällen nicht optimal genutzt werden 10Daten aus dem globalen Register zur Behandlung von Vorhofflimmern zeigen, dass antithrombotische Wirkstoffe zur Verhinderung von Schlaganfällen nicht optimal genutzt werden 11
... 15, 2011 Pharmaceutical companies are dramatically increasing ... meet the demands of a patient-empowered, data-driven, outcomes-focused ... alone, pharmaceutical company investment in smart phone apps, ... other programs increased 78%, as companies embrace a ...
... Unilife Corporation ("Unilife" or "Company") (Nasdaq: ... the three and six months ended December 31, 2010 (Fiscal ... Completed, on-schedule, the construction of a new ... staff now working out of the new facility ...
Cached Medicine Technology:Pharmaceutical Industry Rapidly Expanding Partnerships With New Entrants in Health Care Space, Ernst & Young Finds 2Pharmaceutical Industry Rapidly Expanding Partnerships With New Entrants in Health Care Space, Ernst & Young Finds 3Pharmaceutical Industry Rapidly Expanding Partnerships With New Entrants in Health Care Space, Ernst & Young Finds 4Pharmaceutical Industry Rapidly Expanding Partnerships With New Entrants in Health Care Space, Ernst & Young Finds 5Unilife Corporation Announces Financial Results For Fiscal Year 2011 Second Quarter 2Unilife Corporation Announces Financial Results For Fiscal Year 2011 Second Quarter 3Unilife Corporation Announces Financial Results For Fiscal Year 2011 Second Quarter 4Unilife Corporation Announces Financial Results For Fiscal Year 2011 Second Quarter 5Unilife Corporation Announces Financial Results For Fiscal Year 2011 Second Quarter 6Unilife Corporation Announces Financial Results For Fiscal Year 2011 Second Quarter 7
(Date:9/2/2014)... September 02, 2014 The new ... to reduce discomfort and fatigue by absorbing stress and ... eco-friendly, renewable bio-foam core, these anti-fatigue mats are intended ... According to a study by the Texas A&M University, ... difference in reducing spinal compression and increase in sit-reach ...
(Date:9/2/2014)... A little white pill may help scientists learn why ... their peers, even if their lungs are relatively healthy. ... marketed as Revatio to treat pulmonary hypertension and Viagra ... of over-the-counter antioxidants will help them identify the root ... for these patients. , "We want to understand ...
(Date:9/2/2014)... increasing concern to health officials both in NYC and ... Health and Mental Hygiene, the number of unintentional opioid-involved ... of such deaths in 2000. Much of the increase ... prescription opioid (PO) use among teens and young adults, ... transitioned from POs to heroin. , Now researchers ...
(Date:9/2/2014)... new guideline, the Society for Maternal-Fetal Medicine has recommended ... , "There is no evidence that bed rest ... Center for Maternal and Fetal Medicine and one of ... that bed rest can be harmful for moms, babies, ... are placed on bed rest during their pregnancy. Surveys ...
(Date:9/2/2014)... -- Many people believe that marijuana is not addictive, ... more people are able to obtain and consume cannabis ... people are less likely to perceive it as addictive ... Massachusetts General Hospital,s Center for Addiction Medicine, said in ... cannabis use can have significant consequences, and we know ...
Breaking Medicine News(10 mins):Health News:New Eco-Pro Premium Anti-fatigue Mats from Martinson-Nicholls Prevent Fatigue and Discomfort for Standing Workers 2Health News:Drug that improves blood flow may help find cause of exercise intolerance in cystic fibrosis 2Health News:Drug that improves blood flow may help find cause of exercise intolerance in cystic fibrosis 3Health News:Drug that improves blood flow may help find cause of exercise intolerance in cystic fibrosis 4Health News:NYC teens and young adults who abuse prescription at high risk for overdose 2Health News:NYC teens and young adults who abuse prescription at high risk for overdose 3Health News:SMFM releases paper on activity restriction in pregnancy 2Health News:'Pot Addiction' May Be Real, Study Suggests 2
... Intimidation often takes place during the school day, survey ... is often assumed that the schoolyard is where bullies ... study suggests that classrooms are another popular site. ... Health Association,s annual meeting in Philadelphia, is based on ...
... deductibles and offering little gap coverage , FRIDAY, ... standalone Medicare prescription drugs plans (PDP) could encounter significant ... Monthly premiums will rise 11 percent to $38.94, on ... J. Kaiser Family Foundation. That,s up 50 percent from ...
... citizens managing diabetes and vision loss have ... to help them learn how to stay active, eat sensibly and ... expanded AFB Senior Site ( www.afb.org/seniorsite/diabetes ... at Ruth Eckerd Hall in recognition of American Diabetes ...
... that they are similar in many respects to the body,s ... Institutet have found a new way of tackling colon cancer. ... . Molecular signal pathways that stimulate the division of ... tumour growth. This limits the possibility of treating cancer as ...
... - Researchers from Boston University School of Medicine (BUSM) have ... around the heart and the aorta and within the liver, ... appears on-line in Obesity , also found that measuring ... the amount of undesired fat in and around these vital ...
... ... first aid products designed for active lifestyles, today announced its participation at the Silicon ... , ... (PRWEB) November 13, 2009 -- Tender Corp ., a leading manufacturer of over-the-counter ...
Cached Medicine News:Health News:Many Kids Feel Threatened in the Classroom 2Health News:Medicare Part D: What to Expect This Open Enrollment Period 2Health News:Medicare Part D: What to Expect This Open Enrollment Period 3Health News:AFB Senior Site Offers New Information to Help Senior Citizens Manage Diabetes and Vision Loss 2Health News:AFB Senior Site Offers New Information to Help Senior Citizens Manage Diabetes and Vision Loss 3Health News:AFB Senior Site Offers New Information to Help Senior Citizens Manage Diabetes and Vision Loss 4Health News:Paradoxical protein might prevent cancer 2Health News:Fat collections linked to decreased heart function 2Health News:Tender Corp. Announces Participation at Silicon Valley Moms Group's Holiday Coupon Guide & Party 2Health News:Tender Corp. Announces Participation at Silicon Valley Moms Group's Holiday Coupon Guide & Party 3Health News:Tender Corp. Announces Participation at Silicon Valley Moms Group's Holiday Coupon Guide & Party 4Health News:Tender Corp. Announces Participation at Silicon Valley Moms Group's Holiday Coupon Guide & Party 5
... a national reference laboratory and a worldwide ... ARUP offers an extensive test menu of ... clinical and anatomic pathology. Owned by the ... more than half of the nation's university ...
... ARUP Laboratories is a national reference ... laboratory research and development. ARUP offers an ... unique medical tests in clinical and anatomic ... ARUP Laboratories' clients include more than half ...
... Laboratories is a national reference laboratory and ... and development. ARUP offers an extensive test ... tests in clinical and anatomic pathology. Owned ... clients include more than half of the ...
... ARUP Laboratories is a national reference laboratory ... research and development. ARUP offers an extensive ... medical tests in clinical and anatomic pathology. ... Laboratories' clients include more than half of ...
Medicine Products: