- REVLIMID Granted Approval for Treatment of Patients with Relapsed or Refractory Multiple Myeloma in China
- REVLIMID Granted Priority Review as Treatment for Patients with Relapsed or Refractory Mantle Cell Lymphoma – U.S. FDA PDUFA Date Set for June 5, 2013
BOUDRY, Switzerland–(BUSINESS WIRE)–
Celgene International Sàrl, a subsidiary of Celgene Corporation (CELG), today 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.
About REVLIMID
REVLIMID is approved in combination with dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy in nearly 70 countries, encompassing Europe, the Americas, the Middle-East and Asia, and in combination with dexamethasone for the treatment of patients whose disease has progressed after one therapy in Australia and New Zealand.
REVLIMID is also approved in the United States, Canada, Switzerland, Australia, New Zealand and several Latin American countries, as well as Malaysia and Israel, for transfusion-dependent anaemia due to low- or intermediate-1-risk MDS associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities. Marketing Authorization Applications are currently being evaluated in a number of other countries.
About Celgene
Celgene International Sàrl, located in Boudry, in the Canton of Neuchâtel, Switzerland, is a wholly owned subsidiary and international headquarters of Celgene Corporation.
Celgene Corporation, headquartered in Summit, New Jersey, is an integrated global pharmaceutical company engaged primarily in the discovery, development and commercialization of innovative therapies for the treatment of cancer and inflammatory diseases through gene and protein regulation. For more information, please visit the Company’s website at www.celgene.com.
SOURCE: Celgene
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- REVLIMID Granted Approval for Treatment of Patients with Relapsed or Refractory Multiple Myeloma in China
- REVLIMID Granted Priority Review as Treatment for Patients with Relapsed or Refractory Mantle Cell Lymphoma – U.S. FDA PDUFA Date Set for June 5, 2013
BOUDRY, Switzerland–(BUSINESS WIRE)–
Celgene International Sàrl, a subsidiary of Celgene Corporation (CELG), today 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.
About REVLIMID
REVLIMID is approved in combination with dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy in nearly 70 countries, encompassing Europe, the Americas, the Middle-East and Asia, and in combination with dexamethasone for the treatment of patients whose disease has progressed after one therapy in Australia and New Zealand.
REVLIMID is also approved in the United States, Canada, Switzerland, Australia, New Zealand and several Latin American countries, as well as Malaysia and Israel, for transfusion-dependent anaemia due to low- or intermediate-1-risk MDS associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities. Marketing Authorization Applications are currently being evaluated in a number of other countries.
About Celgene
Celgene International Sàrl, located in Boudry, in the Canton of Neuchâtel, Switzerland, is a wholly owned subsidiary and international headquarters of Celgene Corporation.
Celgene Corporation, headquartered in Summit, New Jersey, is an integrated global pharmaceutical company engaged primarily in the discovery, development and commercialization of innovative therapies for the treatment of cancer and inflammatory diseases through gene and protein regulation. For more information, please visit the Company’s website at www.celgene.com.
SOURCE: Celgene
Post Views: 281
