Corporate Banner
Satellite Banner
RNAi
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 3,200+ scientific posters on ePosters
  • More than 4,600+ 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 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 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
Revealing the Genetic Causes of Bowel Cancer
A landmark study has given the most detailed picture yet of the genetics of bowel cancer — the UK's fourth most common cancer.
Self-Assembling Protein Shell for Drug Delivery
Made-to-order nano-cages open possibilities of shipping cargo into living cells or fashioning small chemical reactors.
Fighting Resistant Blood Cancer Cells
Biologists present new findings on chronic myeloid leukemia and possible therapeutic approaches.
Tumor Cells Develop Predictable Characteristics
Scientists have discovered that cancer cells at the edge of a tumor that are close to the surrounding environment are predictably different from the cells within the interior of the tumor.
Guided Chemotherapy Missiles
Latching chemotherapy drugs onto proteins that seek out tumors could provide a new way of treating tumors in the brain or with limited blood supply that are hard to reach with traditional chemotherapy.
Solutions for Biotherapeutic Characterization
Innovation to speed the routine.
What Makes a Good Scientist?
It’s the journey, not just the destination that counts as a scientist when conducting research.
Biomarkers That Could Help Give Cancer Patients Better Survival Estimates Discovered
UCLA research may also help scientists suppress dangerous genetic sequences.
Body’s Own Gene Editing System Generates Leukemia Stem Cells
Inhibiting the editing enzyme may provide a new therapeutic approach for blood cancers.
A New Approach to Chemical Synthesis
Communesins, originally found in fungus, could hold potential as cancer drugs.
SELECTBIO

SELECTBIO Market Reports
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
3,200+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
4,600+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FOR FREE!