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 3,300+ scientific posters on ePosters
  • More than 4,900+ 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 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
Gene Therapy for Metabolic Liver Diseases
Researchers have tested gene therapy in pigs from hereditary tyrosinemia type 1, with corrected liver cells being transplanted into the diseased liver.
Gene Terapy for Muscle Wasting Developed
New gene therapy could save millions of people suffering from muscle wasting disease.
Testing Nanoparticle Drug Delivery in Dogs
Scientists have tested a nanoparticle drug delivery against bone cancer in dogs with promising results.
Fighting Cancer Through Protein Pathways
Researchers have found a new drug target within a protein production pathway critical to regulating growth and proliferation of cells.
Triple-Action Therapy Patch Shows Promise
Patch that delivers drug, gene, and light-based therapy to tumor sites shows promising results in mice.
Cancer Gene-Drug Combinations Ripe for Precision Medicine
The study aims to expand the number of cancer gene mutations that can be paired with a precision therapy.
Exploiting Malaria’s Achilles’ Heel
Researchers have uncovered an Achilles' heel in malaria's anti-drug treatment arsenal that could lead to a disease cure.
Targeting BRAF Mutations in Thyroid Cancer
Treating metastatic thyroid cancer patients harboring a BRAF mutation with vemurafenib showed anti-tumor activity in a third of patients.
Colon Cancer Blocked in Mice
Case Western Reserve University Researchers block common type of colon cancer tumour in mice, laying groundwork for human clinical trial.
Protein Nanocages Could Improve Drug Design and Delivery
HHMI scientists have designed and built 10 large protein icosahedra that are similar to viral capsids that carry viral DNA.
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
3,300+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
4,900+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FOR FREE!