Satellite Banner
Technology
Networks
Scientific Communities
 
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 3,500+ scientific posters on ePosters
  • More Than 5,000+ 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

Jounce, Celgene Launch $2.6Bn Cooperation
Celgene and Jounce announce collaboration to develop next-gen immuno-oncology therapies for cancer patients.
Wednesday, July 20, 2016
Celgene Announces $50M in Cancer Collaborations
Pioneering public-private cancer initiative with unified leadership committed to changing the course of cancer care.
Thursday, June 23, 2016
Agios, Celgene Establish New Collaboration
New collaboration builds on Agios research platform and leverages Celgene capabilities; Agios to receive $200 million upfront payment.
Thursday, May 19, 2016
Celgene Completes Acquisition of Receptos
Significantly enhances Celgene's I&I franchise with the addition of Ozanimod, potentially a best-in-class oral agent in Phase III trials for inflammatory bowel disease and multiple sclerosis.
Thursday, September 03, 2015
Celgene to Acquire Receptos
This move significantly enhances Celgene's I&I franchise with the addition of Ozanimod, potentially a best-in-class oral agent in phase III trials for Inflammatory Bowel Disease and Multiple Sclerosis
Monday, July 20, 2015
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
Point of Care Diagnostics - A Cautious Revolution
Advances in molecular biology, coupled with the miniaturization and improved sensitivity of assays and devices in general, have enabled a new wave of point-of-care (POC) or “bedside” diagnostics.
Mass Spec Technology Drives Innovation Across the Biopharma Workflow
With greater resolving power, analytical speed, and accuracy, new mass spectrometry technology and techniques are infiltrating the biopharmaceuticals workflow.
One Step Closer to Precision Medicine for Chronic Lung Disease Sufferers
A study led by University of North Carolina at Chapel Hill, and National Jewish Health, has provided evidence of links between SNPs and known COPD blood protein biomarkers.
Charles River Acquires Agilux
Enhances Charles River’s early-stage capabilities in bioanalytical services.
Scientists Find Lethal Vulnerability in Treatment-Resistant Lung Cancer
The study describes how the drug Selinexor killed lung cancer cells and shrank tumors in mice when used against cancers driven by the aggressive and difficult-to-treat KRAS cancer gene.
How Baby’s Genes Influence Birth Weight And Later Life Disease
The large-scale study could help to target new ways of preventing and treating these diseases.
Genes Underlying Dogs’ Social Ability Revealed
The social ability of dogs is affected by genes that also seem to influence human behaviour, according to a new study from Linköping University in Sweden.
‘Cellbots’ Chase Down Cancer, Deliver Drugs Directly to Tumors
Programmable T cells shown to be versatile, precise, and powerful in lab studies.
Drug to Treat Alcohol Use Disorder Shows Promise Among Drinkers With High Stress
The findings suggest that potential future studies with drugs targeting vasopressin blockade should focus on populations of people with AUD who also report high levels of stress.
C Dots Show Powerful Tumor Killing Effect
Nanoparticles known as Cornell dots, or C dots, have shown great promise as a therapeutic tool in the detection and treatment of cancer.
Scroll Up
Scroll Down
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
3,500+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
5,000+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FOR FREE!