VELCADE (Bortezomib) receives European marketing authorisation

ghted that marketing authorisation for VELCADE has been granted, as it is the first major advance for patients with multiple myeloma in more than a decade, and marks the company's commitment to Oncology." said Ken Watters, European Medical Director, Ortho Biotech.

"The approval of VELCADE today brings renewed hope to thousands of European multiple myeloma patients and their families" said Eric Low, Executive Director, International Myeloma Foundation (UK). "The multiple myeloma advocacy community has campaigned tirelessly over the years for cutting edge treatments such as VELCADE to be made available to patients, this is a very proud day", he continued.

The findings of a pre-specified interim analysis from an ongoing phase III trial which compared VELCADE to dexamethasone in refractory multiple myeloma patients found a statistically significant improvement in time to disease progression the primary endpoint of the trial in patients receiving VELCADE compared to patients receiving high-dose dexamethasone. Patients in the control arm of the trial were given the opportunity to switch to VELCADE as soon as possible based on an interim analysis that found a statistically significant improvement in TTP in patients receiving VELCADE compared to patients receiving dexamethasone.

VELCADE has a generally predictable, manageable safety profile (with appropriate monitoring and if necessary, dose modification). VELCADE is contraindicated in patients with hypersensitivity to bortezomib, boron, or mannitol. There are approximately 50 ongoing clinical trials (in Europe and the US) investigating the potential of VELCADE in all stages of multiple myeloma and other cancers.

A single licence has been granted to market VELCADE in the 15 member states of the EU, plus Norway and Iceland. In addition it will be available in the 10 accession countries.

VELCADE is being co-developed by Millennium Pharmaceuticals, Inc. and Johnson & Johnson Ph

Contact: Eva Reynolds

Page: 1 2 3

Related medicine news :

1. VELCADE(TM) data confirms long-term survival
2. UIC professor receives international humanitarian award
3. Mailman School of Public Health receives Manhattan Tobacco Cessation Center grant
4. Epidemiologist Trichopoulos receives $5.8 million Department of Defense Innovator Award
5. GlaxoSmithKline receives unanimous favorable recommendation by FDA Advisory Committee for Boostrix
6. NYU Child Study Center receives grant from the American Red Cross September 11 recovery program
7. Northwestern Memorial Hospital receives $10 million commitment to support preeminent heart program
8. American Academy of Neurology program receives Grassroots Award
9. Orqis receives FDA approval to expand clinical trial of Cancion CRS therapy to 40 centers
10. Mayo Clinic Cancer Center receives SPORE grant for brain cancer research from NCI
11. Pfizers antifungal medicine VFEND receives FDA approval

Post Your Comments:

(Date:11/24/2015)... ... November 24, 2015 , ... Eric C. Seidel, DMD and ... of the revolutionary BIOLASE WaterLase iPlus 2.0™ system. This advanced laser technology uses ... a dentist in Gettysburg, PA . From routine visits to cosmetic treatments, ...
(Date:11/24/2015)... ... November 24, 2015 , ... Charitable giving is at its ... made in the last five weeks of the year totalling over $358 billion in ... to connect the nation’s charities with those individuals who want to “give back” during ...
(Date:11/24/2015)... ... November 24, 2015 , ... DMG Productions announced that they ... airing first quarter 2016 via Discovery Channel. Dates and show times TBA. , Aphria, ... is in the business of producing and supplying medical marijuana pursuant to the Marijuana ...
(Date:11/24/2015)... ... 24, 2015 , ... The Trustees, Massachusetts’ largest conservation and ... fees at several of their most popular properties, including Crane Beach in Ipswich, ... REI’s Black Friday #OptOutside Campaign. The Trustees encourage families and friends to take ...
(Date:11/24/2015)... ... 2015 , ... Cancer patients, survivors, caregivers, family members and ... taping of the next CURE Connections® video series on Saturday, Dec. ... at Georgetown University Hotel & Conference Center in Washington, D.C. , CURE Connections, ...
Breaking Medicine News(10 mins):
(Date:11/24/2015)... Nueva York , 24 de noviembre de ... del Avery Breathing Pacemaker System, se complace anunciar ... Ph.D. como consultor clínico. http://photos.prnewswire.com/prnh/20151124/290596 ... Foto - http://photos.prnewswire.com/prnh/20151124/290596   ... Jonzon es un fisiólogo y consultor en neonatología ...
(Date:11/24/2015)... NEWS, Va. , Nov. 24, 2015  DILON ... they have signed an agreement for DILON to distribute ... geographies across the globe. The signing of this distribution agreement ... Discovery NM750b Molecular Breast Imaging system and is considered ... to provide better healthcare solutions for clinicians and their ...
(Date:11/24/2015)... 24, 2015 Sectra (STO: SECT ... entered into a multi-year agreement to deploy Breast ... will provide the Breast Center a future-proof platform capable ... (STO: SECT B) announces that Breast Center of Acadiana ... Breast Imaging PACS in its two freestanding imaging centers. ...
Breaking Medicine Technology:
Cached News: