Celgene International Sàrl, a subsidiary of Celgene Corporation, reported that the on recommendation from the Data Monitoring Committee (DMC) the company plans to discontinue its pivotal double-blinded phase III Mainsail trial that was designed to evaluate the efficacy and safety of docetaxel and prednisone with or without lenalidomide in patients with castrate-resistant prostate cancer (CRPC).
It was determined that the combination of docetaxel and prednisone plus lenalidomide would not demonstrate a statistically significant treatment effect against the primary endpoint of overall survival versus docetaxel and prednisone plus placebo. We have accepted this recommendation of the DMC and following formal notification and review of the analysis, physicians and patients, internationally, will be officially advised of this action.
Revlimid is not approved as a treatment for patients with prostate cancer.
Revlimid is an IMiDs compound. Revlimid and other IMiDs continue to be evaluated in over 300 clinical trials worldwide. 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 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 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.
Celgene continues to be a pioneer in creating environments since 1998 in which patients can benefit from our disease-altering therapies safely. As a result, hundreds of thousands of patients worldwide have accessed the clinical benefits of our therapies through our performance-based risk management programs including, S T E P S, RevAssist and RevMate, which form the foundation of our commitment to patient safety.
Revlimid (lenalidomide) in combination with dexamethasone is indicated for the treatment of multiple myeloma (MM) patients who have received at least one prior therapy.
Revlimid is indicated for 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.