Navigation Links
CTI to Meet With the FDA to Discuss Filing of a Supplemental Biologics License Application for Zevalin(R)
Date:7/21/2008

ved the median progression-free survival time from 13.5 months (control arm) to 37 months (p<0.0001).

The primary investigators of the study concluded that Zevalin consolidation of first remission in advanced stage follicular non-Hodgkin's lymphoma is highly effective, resulting in a total complete response (CR + CRu) rate of 87 percent and prolongation of median progression-free survival (PFS) by approximately two years, with a toxicity profile comparable to that seen with Zevalin's use in approved indications. Zevalin-treated patients had reversible Grade 3 or 4 hematologic side effects including neutropenia in 67 percent, thrombocytopenia in 61 percent, and anemia in 3 percent. Nonhematologic toxicities were 24% Grade 3, 5% Grade 4, and Grade 3/4 infection was 8%.

About Zevalin(R)

Zevalin(R) (Ibritumomab Tiuxetan) is a form of cancer therapy called radioimmunotherapy and is indicated as part of the Zevalin therapeutic regimen for treatment of relapsed or refractory, low-grade or follicular B-cell non-Hodgkin's lymphoma, including patients with rituximab refractory follicular NHL. Zevalin is indicated under accelerated approval for the treatment of relapsed or refractory, rituximab-nave, low-grade and follicular NHL based on studies using a surrogate endpoint of overall response rate. It was approved by the FDA in February of 2002 as the first radioimmunotherapeutic agent for the treatment of NHL.

Rare deaths associated with an infusion reaction symptom complex have occurred within 24 hours of rituximab (Rituxan(R)) infusions. Yttrium-90 Zevalin administration results in severe and prolonged cytopenias in most patients. Severe cutaneous and mucocutaneous reactions have been reported. The most serious adverse reactions of the Zevalin therapeutic regimen were primarily hematologic, including neutropenia, thrombocytopenia and anemia. Infusion-related toxicities were associated with pre-administration of rituximab. The risk of hematologic t
'/>"/>

SOURCE Cell Therapeutics, Inc.
Copyright©2008 PR Newswire.
All rights reserved

Page: 1 2 3 4

Related medicine technology :

1. Public Forum to Discuss Addiction as a Treatable Disease and Highlight National Alcohol and Drug Addiction Recovery Month
2. Cell Therapeutics, Inc. (CTI) Sponsors Panel Discussion on Women and Lung Cancer on Capitol Hill
3. Cell Therapeutics, Inc. (CTI) Supports Panel Discussion on Women and Lung Cancer on Capitol Hill
4. Threshold to Host Conference Call to Discuss Results From Clinical Presentations at European Cancer Conference (ECCO)
5. Most Women With HIV and Their Health Care Providers Have Not Discussed How HIV Might Affect Them Differently Than Men
6. APIC Conference to Discuss MRSA Elimination
7. ReachMD Broadcasts First-of-its-Kind Physician Peer-Peer Discussion on ENHANCE Trial
8. Mayo Clinic Proceedings Contributors Discuss Impact of Donor Organ Allocation System
9. Rigel to Host Conference Call to Discuss Preliminary Phase 2 Study Results of R788 in Lymphoma
10. Cell Therapeutics, Inc. (CTI) to Hold Conference Call to Discuss Agreement With Bayer Schering Pharma for Access to Phase III Zevalin(R) FIT Trial Data
11. Medivation to Host Conference Call at 5 p.m. EDT Monday to Discuss Top-Line Phase 2 Study Results in Huntingtons Disease
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:12/24/2014)... 2014  Medical Science Liaisons play a large role ... the medical device industry and key stakeholders, the role ... years as the device industry relies on them to ... by benchmarking firm, Best Practices, LLC, one area where ... is by harnessing new technology to enable education. Online ...
(Date:12/22/2014)... Mass. , Dec. 22, 2014 ... leading manufacturer of innovative dialysis products, announced today ... has cleared its System One™ to perform hemodialysis ... known as home nocturnal hemodialysis. NxStage,s® System One ... by the FDA for this indication. ...
(Date:12/22/2014)... , Dec. 22, 2014 Research and Markets ... of the "US Self-monitoring Blood Glucose Market" ... http://photos.prnewswire.com/prnh/20130307/600769 This market insight focuses on ... the United States . Reimbursement analysis ... Thorough product analyses for more than 73 SMBG meters ...
Breaking Medicine Technology:Role of Medical Science Liaisons Evolving in Medical Device Sector 2NxStage Receives FDA Clearance for Home Nocturnal Hemodialysis 2NxStage Receives FDA Clearance for Home Nocturnal Hemodialysis 3US Self-monitoring Blood Glucose Market 2
(Date:12/25/2014)... Overeating is common during the holidays, but there are strategies ... "Don,t arrive at a party hungry. It may seem ... attending a party, but deprivation leads to hunger, and hunger ... Hospital in Mount Kisco, N.Y., said in a hospital news ... and even to have a snack before attending a party ...
(Date:12/25/2014)... Thompson HealthDay Reporter WEDNESDAY, ... in on a "fountain of youth" drug that can delay ... adults, a new study suggests. Seniors received a significant ... targets a genetic signaling pathway linked to aging and immune ... The experimental medication, a version of the drug rapamycin, ...
(Date:12/25/2014)... (PRWEB) December 25, 2014 Thousands of ... move forward in a number of multidistrict litigations currently ... Virginia, Bernstein Liebhard LLP reports. According to an Order ... to convene a Joint Status Conference in all of ... Parties have been directed to submit a proposed agenda ...
(Date:12/25/2014)... 25, 2014 Plugin creators from Pixel ... A fully customizable business presentation tool made specifically for ... ProFire 5k business tool, users can now display their ... of Pixel Film Studios. “ProFire 5k gives users a ... add professionalism to a presentation” , Pixel Film Studios ...
(Date:12/25/2014)... Each year trauma accounts for approximately 42 ... across the nation (according to the Centers for ... Hospital Ambulatory Medical Care Survey collected data from ... They estimated that there were between 3.5 and 4.4 ... diagnosis of broken bone or fracture. , When ...
Breaking Medicine News(10 mins):Health News:Researchers Take 'First Baby Step' Toward Anti-Aging Drug 2Health News:Researchers Take 'First Baby Step' Toward Anti-Aging Drug 3Health News:Federal Court Overseeing Thousands of Transvaginal Mesh Lawsuits Set to Convene Joint Status Conference for All Litigations, Bernstein Liebhard LLP Reports 2Health News:Federal Court Overseeing Thousands of Transvaginal Mesh Lawsuits Set to Convene Joint Status Conference for All Litigations, Bernstein Liebhard LLP Reports 3Health News:Federal Court Overseeing Thousands of Transvaginal Mesh Lawsuits Set to Convene Joint Status Conference for All Litigations, Bernstein Liebhard LLP Reports 4Health News:Announcing a new ProFire 5k plugin from Pixel Film Studios for Final Cut Pro X Professionals 2Health News:Every Year Four Million Emergency Department Visits Result from Accidents Involving Bone Trauma 2Health News:Every Year Four Million Emergency Department Visits Result from Accidents Involving Bone Trauma 3Health News:Every Year Four Million Emergency Department Visits Result from Accidents Involving Bone Trauma 4
... (HealthDay News) -- More patients and families are using Facebook ... do improves the chances of obtaining a donor organ, a ... in Maywood, Ill., examined 91 Facebook pages that were seeking ... that 12 percent of the pages reported receiving a kidney ...
... Reporter , WEDNESDAY, May 30 (HealthDay News) -- The health ... but new research may add another condition to this list: ... lymph nodes in the groin area. Lymphedema in the ... removal of or damage to the lymph nodes. A blockage ...
... -- Advancements in human genetic research could lead ... protect against the misuse of people,s genetic data, the ... policy recommendations, including U.S. government oversight of genetic tests ... While discoveries in recent years -- such as the ...
... (HealthDay News) -- Scientists who were the first to fully ... step toward improving its yield, nutrition, disease resistance, taste and ... "Heinz 1706" tomato and found that it has about 35,000 ... the tomato -- whether it,s taste, natural pest resistance or ...
... , EVANSTON, Ill. --- American parents may want to ... their children from everyday germs. A new Northwestern ... evidence of chronic low-grade inflammation -- associated with diseases ... In contrast, about one-third of adults in the United ...
... busier than ever, but Case Western Reserve University psychologists ... fact, it appears to have increased. Psychologists ... when they analyzed 14 play studies that Russ conducted ... But as they report in "Changes in Children,s Play ...
Cached Medicine News:Health News:More Families Seek Kidney Donations on Facebook 2Health News:Obesity May Raise Odds for Painful Leg Condition 2Health News:Brave New World of Genetics Requires Safeguards, Experts Say 2Health News:Scientists Map the Tomato's Genome 2Health News:Understanding the links between inflammation and chronic disease 2Health News:Understanding the links between inflammation and chronic disease 3Health News:Despite less play, children's use of imagination increases over 2 decades 2
... The ABI Prism 7000 Sequence ... PCR system that detects and quantitates ... cycle-by-cycle detection of accumulated PCR product ... cycling, fluorescence detection, and application-specific software ...
RIA kit for the determination of autoantibodies to the TSH receptor (TSHR) in serum [with calibrators]....
ELISA kit for the determination of autoantibodies to the TSH receptor (TSHR) in serum....
Coated-Tube (CT) RIA kit for the determination of autoantibodies to the TSH receptor (TSHR) in serum...
Medicine Products: