" "
Satellite Banner
Genomics
Scientific Community
 
Become a Member | Sign in
Home>News>This Article
  News
Return

Celgene Provides REVLIMID® Regulatory Update

Published: Tuesday, February 12, 2013
Last Updated: Tuesday, February 12, 2013
Bookmark and Share
REVLIMID granted approval for treatment of patients with relapsed or refractory multiple myeloma in China.

Celgene International Sàrl announced that REVLIMID® (lenalidomide) has been granted full approval, which includes an Import Drug License (IDL) by the China State Food and Drug Administration (SFDA) for use in combination with dexamethasone as a treatment for patients with relapsed or refractory multiple myeloma who have received at least one prior therapy.

The approval of REVLIMID is based upon the safety and efficacy results of multiple pivotal randomized phase III international clinical trials in patients with relapsed or refractory multiple myeloma. Results from a large, phase II bridging study (MM-021) of lenalidomide and low-dose dexamethasone in 159 Chinese patients, who had relapsed or refractory multiple myeloma, also supported the submission and approval.

Multiple myeloma is the second most commonly diagnosed blood cancer. According to the International Myeloma Foundation, there are an estimated 750,000 people with multiple myeloma worldwide.

REVLIMID will be available only through a proprietary distribution program developed by Celgene. The company is working to supply REVLIMID to the China market as soon as possible. Certain standard government processes must be followed prior to launch. Celgene expects REVLIMID to be available to patients late in the second quarter of 2013.

U.S. Food and Drug Administration (FDA) Priority Review

Celgene was also informed that its application for REVLIMID in patients with relapsed or refractory mantle cell lymphoma (MCL) after prior therapy that included bortezomib has been accepted by the U.S. Food and Drug Administration. The agency has assigned a priority review to the application and has set a Prescription Drug User Fee Act date of June 5, 2013.


Further Information

Join For Free

Access to this exclusive content is for Technology Networks Premium members only.

Join Technology Networks Premium for free access to:

  • Exclusive articles
  • Presentations from international conferences
  • Over 2,900+ scientific posters on ePosters
  • More than 4,200+ scientific videos on LabTube
  • 35 community eNewsletters


Sign In



Forgotten your details? Click Here
If you are not a member you can join here

*Please note: By logging into TechnologyNetworks.com you agree to accept the use of cookies. To find out more about the cookies we use and how to delete them, see our privacy policy.

Related Content

Celgene Launches $1B Immunotherapy Collaboration with Juno
Celgene and Juno Therapeutics have launched a 10-year global collaboration to develop and commercialize cancer and autoimmune diseases immunotherapies.
Wednesday, July 01, 2015
Celgene to Acquire Quanticel Pharmaceuticals
Celgene committed to expanding sustainable pipeline of life-enhancing medical innovation to benefit cancer patients.
Saturday, May 02, 2015
Celgene Announces U.S. FDA Grants Priority Review for ABRAXANE® sNDA
European Medicines Agency accepts regulatory submission of Type II variation for ABRAXANE for the treatment of advanced pancreatic cancer.
Friday, May 24, 2013
Celgene Reports Strong Fourth Quarter and Full Year 2012 Operating and Financial Results
New and Updated Data on Over Ten Pivotal Phase III Trials Expected in 2013.
Friday, January 25, 2013
Celgene Announce Final Phase II Data Evaluating REVLIMID® and Rituximab
The study reported overall response rate of 66% in patients with relapsed or refractory chronic lymphocytic leukemia, with 12% of patients achieving complete response. After a median follow-up of 31 months, overall survival Was 75%.
Wednesday, December 14, 2011
Scientific News
Genetic Cause of Rare Allergy
Institute has identified a genetic mutation responsible for a rare form of inherited hives induced by vibratory urticaria.
Mitochondria Shown to Trigger Cell Ageing
An international team of scientists has for the first time shown that mitochondria, the batteries of the cells, are essential for ageing.
Cancer Cells Kill Off Healthy Neighbours
Cancer cells create space to grow by killing off surrounding healthy cells, according to UK researchers working with fruit flies.
Validating the Accuracy of CRISPR-Cas9
IBS Researchers create multiplex Digenome-seq to find errors in CRISPR-Cas9 processes.
Cancer Drug Target Visualized at Atomic Resolution
New study using cryo-electron microscopy shows how potential drugs could inhibit cancer.
Genetic Mechanism Behind Cancer-Causing Mutations
Researchers at Indiana University has identified a genetic mechanism that is likely to drive mutations that can lead to cancer.
"Gene Fusion" Drives Childhood Brain Cancers
Study co-led by Penn scientists highlights potential targets for future cancer therapies.
Enzyme Links Age-Related Inflammation, Cancer
Researchers have shown that an enzyme key to regulating gene expression -- and also an oncogene when mutated -- is critical for the expression of numerous inflammatory compounds that have been implicated in age-related increases in cancer and tissue degeneration.
How to Unlock Inaccessible Genes
An international team of biologists has discovered how specialized enzymes remodel the extremely condensed genetic material in the nucleus of cells in order to control which genes can be used.
Viral Gene Editing System Corrects Genetic Liver Disease
Penn study has implications for developing safe therapies for an array of rare diseases via new gene cut-and-paste methods.
Skyscraper Banner

Skyscraper Banner
Go to LabTube
Go to eposters
 
Access to the latest scientific news
Exclusive articles
Upload and share your posters on ePosters
Latest presentations and webinars
View a library of 1,800+ scientific and medical posters
2,900+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
4,200+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FOR FREE!