Navigation Links
Pfizer Prepares for Voluntary Withdrawal of U.S. New Drug Application and for Discontinuation of Commercial Availability of Mylotarg®
Date:6/21/2010

positive AML in first relapse who are 60 years of age or older and who are not considered candidates for other cytotoxic chemotherapy.  Patients treated with Mylotarg receive one course of treatment that consists of two doses typically given 14 days apart.

AML is a relatively uncommon disease that affects approximately 13,000 new patients annually in the U.S.  It is estimated that less than 2,500 patients receive Mylotarg annually in the U.S.

SWOG S0106 Post Approval Study

With the agreement of FDA, a Phase 3 randomized, comparative controlled trial (SWOG S0106) using Mylotarg in combination with other chemotherapeutic agents (daunorubicin and cytosine arabinoside) versus chemotherapy alone in first-line AML patients under the age of 61 was conducted to confirm clinical benefit for Mylotarg.  A total of 627 patients were enrolled in this study.  Although SWOG S0106 did not confirm the clinical benefit, the results do not directly impact the risk/benefit profile of Mylotarg in its approved indication as a single agent.

Additionally, among all patients evaluable for early toxicity, the fatal induction toxicity rate was significantly higher in the daunorubicin and cytosine arabinoside + Mylotarg arm compared to the daunorubicin and cytosine arabinoside arm (16/283=5.7% vs. 4/281=1.4%, P=0.01).

About Mylotarg® (gemtuzumab ozogamicin for Injection)

Important safety information:

Mylotarg should be administered under the supervision of physicians experienced in the treatment of acute leukemia and in facilities equipped to monitor and treat leukemia patients.

There are no controlled trials demonstrating efficacy and safety using Mylotarg in combination with other chemother
'/>"/>

SOURCE Pfizer Inc.
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3 4 5 6

Related medicine technology :

1. Pfizer And Epocrates Partner To Give Healthcare Providers Access To Medical Information Specialists For Medication Questions
2. Pfizer Appoints Mikael Dolsten President of Worldwide Research and Development
3. Pfizer Invites Public to View and Listen to Webcast of Pfizer Presentation at Healthcare Conference
4. Pfizer Reigns Supreme After Patent Cliff as Humira Kicks Avastin off Top Spot
5. Gelesis Unveils Novel Non-Invasive Capsulated Device for Obesity and Presents Clinical Data; Appoints Former Pfizer R&D President to Board
6. Pfizers Jeffrey Kindler Becomes PhRMA Board Chairman; Christopher Viehbacher, John Lechleiter Assume New Posts
7. President of Pfizer Vaccines, Mark Swindell, Named as the Healthcare Businesswomens Associations 2010 Honorable Mentor
8. VetCentric Announces Partnership With Pfizer Animal Health
9. Pfizer Selects ChemAxons Markush Platform
10. Pfizer Whistleblower Named Years Most Influential Person In Business Ethics
11. Majority of Surveyed Pharmacy Directors Expect To Cover Pfizers Tanezumab If It Is Approved for the Treatment of Chronic Pain
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/15/2014)... 2014  Valeant Pharmaceuticals International, Inc. (NYSE: VRX ... period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 ... by its indirect wholly-owned subsidiary, Sapphire Subsidiary Corp. ("Purchaser"), ... of Solta Medical, Inc. (NASDAQ: SLTM ) ...
(Date:1/14/2014)... , Jan. 14, 2014 HeartWare International, Inc ... of less invasive, miniaturized circulatory support technologies that are ... that it expects revenues for the fourth quarter of ... 2013 revenues to approximately $208 million. "Our ...
(Date:1/14/2014)... Jan. 14, 2014 /PRNewswire-iReach/ -- Acumed,s new SLIC Screw ... with accompanying instrumentation to place and insert the screw ... soft tissue (e.g. ligament) repair or reconstruction as it ... (Photo: http://photos.prnewswire.com/prnh/20140114/MN45636 ) ...
Breaking Medicine Technology:Valeant Pharmaceuticals Announces Receipt Of Antitrust Clearance For Its Previously Announced Acquisition Of Solta Medical, Inc. 2Valeant Pharmaceuticals Announces Receipt Of Antitrust Clearance For Its Previously Announced Acquisition Of Solta Medical, Inc. 3HeartWare International Announces Preliminary Fourth Quarter 2013 Revenues 2HeartWare International Announces Preliminary Fourth Quarter 2013 Revenues 3HeartWare International Announces Preliminary Fourth Quarter 2013 Revenues 4Acumed introduces the Scapho-Lunate Inter Carpal (SLIC) Screw System 2Acumed introduces the Scapho-Lunate Inter Carpal (SLIC) Screw System 3
... 2009 Convention -- When Shawnae Jebbia won the Miss USA ... career. She appeared at events throughout the world, worked as ... world unexpectedly changed when she was diagnosed with hearing loss. ... had a difficult time understanding and accepting the sudden hearing ...
... eResearchTechnology, Inc. (ERT), (Nasdaq: ERES ), a leading provider ... medical device and related industries, announced today results for the ... Unless otherwise noted, all comparative numbers refer to changes from ... , Financial highlights for the third quarter of 2009: ...
Cached Medicine Technology:Former Miss USA Shawnae Jebbia Shines with Siemens Pure 2Former Miss USA Shawnae Jebbia Shines with Siemens Pure 3ERT Reports Third Quarter 2009 Results 2ERT Reports Third Quarter 2009 Results 3ERT Reports Third Quarter 2009 Results 4ERT Reports Third Quarter 2009 Results 5ERT Reports Third Quarter 2009 Results 6ERT Reports Third Quarter 2009 Results 7ERT Reports Third Quarter 2009 Results 8ERT Reports Third Quarter 2009 Results 9ERT Reports Third Quarter 2009 Results 10ERT Reports Third Quarter 2009 Results 11ERT Reports Third Quarter 2009 Results 12ERT Reports Third Quarter 2009 Results 13
(Date:7/9/2014)... injection drug users in Russia might contribute to ... study, conducted by researchers from Boston University Schools ... St. Petersburg Pavlov State University, sought to discover ... outcomes of a cohort of HIV-positive people with ... were arrested by police were more likely to ...
(Date:7/9/2014)... been a sharp increase in the number of cancer ... online, interactive service that allows patients to view laboratory ... appointments, and renew prescriptions. , Over a six-year period, ... each year increased five-fold, while the number of total ... a study by Dr. David Gerber , Associate ...
(Date:7/9/2014)... may smell of flatulence and have a reputation for being ... hydrogen sulfide is now being being found to offer potential ... stroke, heart attacks and dementia. A new compound (AP39), designed ... key to future therapies, by targeting delivery of very small ... inside cells. , Scientists in Exeter have already found ...
(Date:7/9/2014)... and poor printing on prescription labels handed out ... to errors in taking medication, according to new ... (Canadian National Institute for the Blind)., The study, ... , found that labels on prescription medications dispensed ... guidelines for legibility. , By simply following recommended ...
(Date:7/9/2014)... in Western societies. One frequently cited reason is that ... infections than previous generations, thereby delaying maturation of the ... Academy, University of Gothenburg, monitored children until the age ... in relation to allergic disease. All of the children ... half of them on farms that produced milk.,Lower risk ...
Breaking Medicine News(10 mins):Health News:BU researchers relate arrests with HIV risk environment 2Health News:MyChart use skyrocketing among cancer patients, UT Southwestern study finds 2Health News:MyChart use skyrocketing among cancer patients, UT Southwestern study finds 3Health News:Rotten egg gas holds key to healthcare therapies 2Health News:Most prescription labels fail to meet guidelines, risking dosage errors 2
... impact film scenes have on their kids, , , TUESDAY, March ... drinking alcohol should be factored into movie ratings, fewer than ... rating for a film. , And, only about one-quarter ... on its own to justify an R rating. Yet, ...
... analyst for Lincoln Park Zoo,s Urban Wildlife Institute was ... worldwide to receive the prestigious Smith Fellowship from the ... It is recognized as the nation,s premier post doctoral ... is aimed at finding solutions to the most urgent ...
... WESTLAKE VILLAGE, Calif., March 3 /PRNewswire/ ... announced today that it is expanding the states ... SOC is the country,s largest private provider of ... managed more than 5,500 emergency neurology consultations to ...
... partnership with the Forum, Unveil Disease "Hot Spots" - ... - an alliance of patient advocates, dialysis ... quality of care for individuals with kidney disease and ... the racial disparity among those suffering from Chronic Kidney ...
... America, Inc., a leading medical diagnostic instrument manufacturer ... of the Sysmex WAM eLearning program to its ... the U.S. Sysmex WAM eLearning gives customers a ... WAM users and as a tool to assist ...
... entitled Motorcycle Cancer? is sending a ... seat extremely low frequency electromagnetic field (ELF EMF) ... Randall Dale Chipkar. "Science proves electromagnetic danger and ... read up to 500 milliGauss of ELF EMF ...
Cached Medicine News:Health News:Smoking, Drinking Should Matter in Movie Ratings, Parent Survey Finds 2Health News:Smoking, Drinking Should Matter in Movie Ratings, Parent Survey Finds 3Health News:Lincoln Park Zoo researcher awarded prestigious conservation biology fellowship 2Health News:Specialists On Call Expands Access to Emergency Neurology On-Call Services in Montana 2Health News:Kidney Care Partners Raises Alarm on Racial Disparities in Kidney Disease; Joins With National Minority Quality Forum to Educate Public, Congress During National Kidney Month 2Health News:Kidney Care Partners Raises Alarm on Racial Disparities in Kidney Disease; Joins With National Minority Quality Forum to Educate Public, Congress During National Kidney Month 3Health News:Sysmex America Introduces On Demand Middleware Training Tool 2Health News:Motorcycle Cancer Risk: Motorcycle Cop Cancer Concern from ELF EMFs Penetrating Motorcycle Seats 2
8 X 1 Red Filter. Color Filters are designed to filter out all other color regions of the visible spectrum except the specified color. Color Filters are excellent for contrast enhancement and color r...
Features a twist-on backswitch, with a diffused, cobalt blue light beam....
Heavy duty, all purpose illuminator available in black only. Unique Clip Switch automatically turns off when returned to pocket. Pre-focused lens tip Heine XHL Halogen bulb for bright, concentrated l...
... A child-friendly vision ... and takes just seconds. ... the first objective, accurate ... reliable early detection of ...
Medicine Products: