Navigation Links
GlaxoSmithKline and Genmab Submit Arzerra(TM) (Ofatumumab) Application to FDA for the Treatment of Advanced Stage Blood Cancer
Date:1/30/2009

lated to infusion reactions and infections. AEs seen in at least 10 percent of patients included fever, cough, diarrhea, rash, low white blood cell counts, fatigue, pneumonia, anemia, shortness of breath and nausea. In clinical trials to date, infusion reactions that were serious yet manageable were seen in three percent of patients. One case of progressive multifocal leukoencephalopathy (PML), a rare brain infection resulting in death or causing severe disability, and one case of tumor lysis syndrome were reported.(5,6) These data were presented at the 50th Annual Meeting of the American Society of Hematology (ASH) in December 2008.

Potential to Combat CLL in Earlier Stages

The companies also announced today the initiation of an additional Phase III study of ofatumumab in combination with fludarabine and cyclophosphamide (FC) for patients with CLL when initial treatment no longer works (second-line treatment). The open-label study will randomize 352 patients to evaluate progression-free survival (PFS) of ofatumumab in combination with FC therapy versus FC therapy alone for the treatment of relapsed CLL.(7) Enrollment for this study will begin shortly.

"Bolstered by the positive results of ofatumumab for advanced stage CLL, we're now investigating ofatumumab in earlier stages in the treatment continuum," said Paolo Paoletti, M.D., Senior Vice President of Oncology R&D, GSK. "The clues we're seeing from ofatumumab also suggest possible activity in other oncology settings, which we're currently evaluating through several clinical trials."

GSK and Genmab will conduct additional studies of ofatumumab in CLL and non-Hodgkin's lymphoma (NHL) settings. In CLL, a Phase III front-line study is evaluating ofatumumab combined with chlorambucil in patients with previously untreated CLL. In NHL, an ongoing Phase II study will assess ofatumumab in patients with Waldenstrom's Macroglobulinemia - a rare type of
'/>"/>

SOURCE GlaxoSmithKline
Copyright©2009 PR Newswire.
All rights reserved

Page: 1 2 3 4 5 6 7 8

Related medicine news :

1. GlaxoSmithKlines Drug Will Become New Clinical Gold Standard by 2012 for the Treatment of Relapsed/Refractory CLL
2. GlaxoSmithKline Awards Ten Area Healthcare Nonprofits with $40,000 Each in Funding
3. GlaxoSmithKline and Dynavax Announce Worldwide Strategic Alliance : – Developing First-in-Class Endosomal TLR Inhibitors for Autoimmune and Inflammatory Diseases –
4. GlaxoSmithKline Statement on FDA Advisory Committee Vote on Use of Asthma Medicines Containing Long-Acting Beta-Agonists
5. GlaxoSmithKline and The Carter Center Reaffirm Commitment to Global Public Health with Expansion of LF Program
6. GlaxoSmithKline to Acquire the Leading Dry Mouth Brand, Biotene
7. AUDIO from Medialink and GlaxoSmithKline: Give Kids A Boost For Their Health!
8. GlaxoSmithKline Acquires Sirtris Pharmaceuticals, Inc., a World Leader in Sirtuin Research and Development
9. Amira Pharmaceuticals Achieves Milestones in FLAP Inhibitor Program With GlaxoSmithKline
10. Emerging Combination Therapies, Including Drugs from Novartis/Schering-Plough and GlaxoSmithKline/Theravance Will Drive the COPD Drug Market to More Than $11 Billion in 2017
11. Video: GlaxoSmithKline Consumer Healthcare Offers Free Nicotine Lozenges for All Certified Pilots and Air Traffic Controllers to Help Them Safely Quit Smoking
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/25/2014)... October 25, 2014 More than 50 ... Circle Reception on Monday at the home of Jim ... hear from guest speaker Dr. Winifred Lender on finding ... Dr. Lender, a Santa Barbara psychologist, author and Noozhawk ... benefits of living in the digital age. Our digital ...
(Date:10/25/2014)... October 25, 2014 The ... which verifies IT-accessibility for disabled users by disabled ... logo to Mackin Educational Resources of Burnsville, ... management system and to the Minnesota Alliance for ... "Own Best Medicine" website. Both organizations ...
(Date:10/25/2014)... Homeowners that are wondering how they can ... no more. Clean Crawls gives 5 signs of ... when it comes to insulation in their recently released ... by Clean Crawls, can cause problems throughout your entire ... has deteriorated, become damp, or been infested with pests ...
(Date:10/25/2014)... (PRWEB) October 25, 2014 Limbkeepers® announced ... episode of Innovations with Ed Begley Jr, airing 1st ... TBA. , In this episode, Innovations will focus on ... to protect fragile, thinning skin on arms, hands, and ... learn about these versatile products, which help reduce injuries, ...
(Date:10/25/2014)... Not getting the right amount of sleep might raise ... Those who sleep less or more than the ... more prone to developing the chronic condition, which causes ... concluded that duration and quality of sleep are key ... diseases. "Both short and long durations of sleep ...
Breaking Medicine News(10 mins):Health News:Finding Balance between the Real & Digital World Topic of Family Service Agency Reception 2Health News:Finding Balance between the Real & Digital World Topic of Family Service Agency Reception 3Health News:Finding Balance between the Real & Digital World Topic of Family Service Agency Reception 4Health News:IT-Accessibility Award Granted to Education and Health Care for Section 508/WCAG 2Health News:IT-Accessibility Award Granted to Education and Health Care for Section 508/WCAG 3Health News:5 Signs Indicating That Insulation Needs Replacing as Told By Clean Crawls in Recent Article 2Health News:Upcoming Episode of Innovations with Ed Begley, Jr. to Feature Limbkeepers® 2Health News:Sleep Duration Linked to Ulcerative Colitis Risk in Study 2
... Michigan State University have added yet another piece to ... the pancreas, one of the deadliest forms of cancer. ... issue of the International Journal of Cancer, MSU’s James ... which a healthy cell turns cancerous. ,Specifically, ...
... health needs of people in the last phase of life are ... this// week's BMJ. ,Our health care systems do not ... the last phase of life, write Sydney Dy and Joanne Lynn, ... ,Even though contrary evidence is all around us, we use language ...
... nonsurgical embolization is ninty-eight percent effective, offers a lower ... the treatment of varicoceles (varicose veins in the testicle ... testicular atrophy or fertility problems—and can greatly impact quality ... of infertility—it is important for these patients to have ...
... Spanish capital Madrid decided to replace the thin beauty ideal ... of move that millions of women// around the world appeared ... ban very skinny fashion models and to promote healthy images ... a spokesman for the regional government says. ,"Media ...
... warning- the highest level of warning, to the genetically engineered ... , These drugs, such as Epo, are given to ... They are hormone-based drugs, usually derived from kidneys. ... more than a warranted number of complications such as blood ...
... we live in a hardscrabble world that is only going ... University of California, Los Angeles (UCLA) professors who are calling ... system. ,In their report, which appears in ... Halfon, director of the Center for Healthier Children, Families and ...
Cached Medicine News:Health News:MSU Research Strengthens Link Between Smoking, Pancreatic Cancer 2Health News:Health Care Systems for Critically Ill Patients Need Restructuring 2Health News:Nonsurgical Therapy Highly Effective for Pain and Infertility in Men 2Health News:Spain Launches Movement Against Skinny Fashion Models 2Health News:Spain Launches Movement Against Skinny Fashion Models 3Health News:U.S. Child Health System Needs Total Overhaul 2
(Date:10/25/2014)... 2014 Best Practices designed the Medical ... a forum for sharing insights about the key ... mechanism for creating and sharing solutions through three ... from the Medical Affairs Consortium survey. ... the first roundtable of the 2014-2015 Medical Affairs ...
(Date:10/22/2014)... 22, 2014  Rescheduling of hydrocodone combination products ... pain market, according to a new primary market ... providing market research and consultation exclusively in the ... http://photos.prnewswire.com/prnh/20141021/153440 In August, ... combination products from Schedule III to Schedule II ...
(Date:10/22/2014)... HOUSTON , Oct. 22, 2014  Charlene Vernak, RPh, ... York , recently was awarded the George Roentsch ... Vernak received the award in Houston ... The scholarship is awarded annually to an independent pharmacist ... nature of George Roentsch , a well-known pharmacist ...
Breaking Medicine Technology:Strong Participation in Best Practices' Medical Affairs Consortium Survey 2Hydrocodone: Rescheduled, Repositioned & Reinvented 2Hydrocodone: Rescheduled, Repositioned & Reinvented 3PCCA Awards Charlene Vernak, RPh, the George Roentsch Scholarship 2
... HOUSTON, Sept. 29 The Gulf Coast Regional Center ... three companies who will receive up to a total ... Emerging Technology Fund (TETF).   (Logo:   ... The TETF program was established by ...
... Luminex Corporation (Nasdaq: LMNX ), today ... USA Award for its innovative xTAG® Respiratory Viral Panel ... Technology at the Prix Galien USA and International awards ... American Museum of Natural History in New York City. ...
Cached Medicine Technology:Gulf Coast Regional Center of Innovation and Commercialization and Houston Technology Center Announce Recipients of TETF Awards 2Gulf Coast Regional Center of Innovation and Commercialization and Houston Technology Center Announce Recipients of TETF Awards 3Luminex Corporation Wins Prestigious 2010 Prix Galien USA Award 2
... Each kit features a patented Per-fit™ flexible ... and a low-profile cuff specifically designed to ... to the patients anatomy. The kit s ... the tube snugly, allowing for an easier ...
... and cost control. , ,Our full ... variety of wound dressing components for the ... patient. , ,Tray configurations include full ... inner cannula for both rigid and flexible ...
... Self-contained kits provide convenience and cost control. ... care trays offer a variety of wound ... management of the tracheostomized patient. , ... and trays with disposable inner cannula for ...
Disposable tracheostomy care tray....
Medicine Products: