Celgene International Sarl announced that its oral cancer drug Revlimid (lenalidomide) has received recommendation for approval from the Australian Drug Evaluation Committee (ADEC) for use in combination with dexamethasone as a treatment for patients with multiple myeloma whose disease has progressed after one therapy. Multiple myeloma is the second most commonly diagnosed blood cancer.
ADEC's recommendation for approval will be forwarded to the Therapeutic Goods Administration (TGA) for ratification. The TGA generally supports the recommendations of the ADEC and grants marketing approval after the final prescribing information is negotiated and certificates of registration are issued. This process can take anywhere from two to six weeks.
"The ADEC recommendation is an especially important and positive milestone for Celgene. We are fully committed to provide Revlimid to patients in need throughout Australia," said Aart Brouwer, president, Celgene International. "We're optimistic that Revlimid will have broad support based on its clinical benefits to patients. Upon approval we will be initiating the next steps for pricing, reimbursement and distribution." The recommendation for approval from the ADEC was based upon the safety and efficacy results of two large, randomised pivotal phase III special protocol assessment trials, North American Trial MM-009 and International Trial MM-010, evaluating Revlimid plus dexamethasone in multiple myeloma patients whose disease has progressed after one therapy.
"The recommendation for approval of Revlimid from ADEC is an important step towards providing a new oral therapeutic option in Australia for this particular group of patients with multiple myeloma," said Graham Burton, M.D., SVP, Global Regulatory Affairs and Pharmacovigilance, Celgene. "We will continue our work with the Australian authorities to bring Revlimid to patients in need as quickly as possible."
Revlimid is currently also approved in the United States by the US Food and Drug Administration (FDA), in the European Union by the EMEA and in Switzerland for multiple myeloma patients who have received at least one prior therapy. In addition, Revlimid is also approved in the US for treatment of patients with transfusion-dependent anaemia due to low- or intermediate-1-risk Myelodysplastic Syndrome (MDS) associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities. Revlimid has already obtained Orphan Drug designation in the EU, US, Switzerland and Australia for treatment of multiple myeloma and in the EU, US and Australia for MDS.
Revlimid is an IMiDs compound, a member of a proprietary group of novel immunomodulatory agents. Revlimid and other IMiDs compounds continue to be evaluated in over 100 clinical trials in a broad range of haematological and oncological conditions. The IMiDs pipeline is covered by a comprehensive intellectual property estate of issued and pending patent applications in the US, EU and other regions, including composition-of- matter and use patents.
Revlimid has obtained Orphan Drug designation in the EU, US and Australia for treatment of Multiple Myeloma and is already approved for use as a treatment in combination with dexamethasone for patients previously treated with multiple myeloma by the US Food and Drug Administration (FDA). Revlimid is also approved for treatment of patients with transfusion-dependent anaemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities by the FDA.
Multiple myeloma (also known as myeloma or plasma cell myeloma) is a cancer of the blood in which malignant plasma cells are overproduced in the bone marrow. Plasma cells are white blood cells that help produce antibodies called immunoglobulins that fight infection and disease. However, most patients with multiple myeloma have cells that produce a form of immunoglobulin called paraprotein (or M protein) that does not benefit the body. In addition, the malignant plasma cells replace normal plasma cells and other white blood cells important to the immune system. Multiple myeloma cells can also attach to other tissues of the body, such as bone, and produce tumours. The cause of the disease remains unknown.
The Australian Drug Evaluation Committee is appointed by the Minister for Health and Aging and provides advice to the Minister and the Secretary of the Commonwealth Department of Health and Aging through the Therapeutic Goods Administration (TGA), on the quality, risk-benefit, effectiveness and access within a reasonable time of any drug referred to it for evaluation, as well as medical and scientific evaluations of applications for registration of prescription drugs.
The Therapeutic Goods Administration is the regulatory body for therapeutic goods in Australia. It is a Division of the Australian Department of Health and Aging and is responsible for conducting assessment and monitoring activities to ensure that therapeutic goods available in Australia are of an acceptable standard and that access to therapeutic advances is in a timely manner.
Celgene International Sarl, located in Neuchatel, Switzerland, is a wholly owned subsidiary and international headquarters of Celgene Corporation. Celgene Corporation, headquartered in Summit, New Jersey, is an integrated global biopharmaceutical company engaged primarily in the discovery, development and commercialisation of innovative therapies for the treatment of cancer and inflammatory diseases through gene and protein regulation.