Celgene Provides REVLIMID® Regulatory Update
News Feb 12, 2013
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.
Easily Automate PK Assays for Human IgG Drugs in Preclinical SpeciesNews
At AAPS NBC event, Lumigen produced a poster summarizing the use of their pipetting robot, Andrew which can measure IgG drug concentration in a pre-clinical setting.READ MORE
Could This Be a "Silver Bullet" for Preventing and Treating Colon Cancer?News
A team of scientists targeted the gene CtBP with a drug known as HIPP (2-hydroxy-imino phenylpyruvic acid) and were able to reduce the development of pre-cancerous polyps by half.READ MORE
FDA Grants Full Approval to Blinatumomab for Acute Lymphoblastic LeukemiaNews
TheFDA has changed its accelerated approval of blinatumomab (Blincyto®) for some patients with acute lymphoblastic leukemia to a full approval and expanded the approved indications for its use.READ MORE
Comments | 0 ADD COMMENT
6th Edition of International Conference on Pharmacognosy and Medicinal Plants
Apr 16 - Apr 17, 2018
11th International Conference on Cancer Stem Cells
Jun 11 - Jun 13, 2018