FDA Statement: FDA halts clinical trial of drug Revlimid (lenalidomide) for chronic lymphocytic leukemia due to safety concerns

[7-18-2013] The U.S. Food and Drug Administration (FDA) halted a clinical trial of the anti-cancer drug Revlimid (lenalidomide) because of significant safety concerns. The ORIGIN trial (NCT00910910), which was evaluating Revlimid treatment for a new use as an initial therapy for chronic lymphocytic leukemia (CLL) in patients 65 years and older, showed higher rates of death in patients treated with Revlimid compared to those treated with chlorambucil. In addition, FDA has determined that the clinical trial is unlikely to achieve its main objective to reduce the amount of time for the leukemia to progress or the patient to die. FDA is continuing to review the trial results and will communicate any additional important information from its investigation. Patients with CLL receiving Revlimid should discuss their treatment options with their health care professionals.

Health care professionals should be aware that Revlimid is not approved to treat CLL. Tumor flare reactions have occurred during investigational use of Revlimid for CLL. Patients should talk to their health care professionals if they have any questions or concerns about Revlimid.
Revlimid is still considered safe and effective for the following approved uses:

Treatment of patients with multiple myeloma who have received at least one prior medicine, when taken along with the medicine dexamethasone.
Treatment of patients who have a type of myelodysplastic syndrome (MDS) known as deletion 5q MDS, where part of chromosome 5 is missing. Patients with this type of MDS may have low red blood cell counts that require treatment with blood transfusions.
Treatment of patients with mantle cell lymphoma whose disease does not respond to or comes back after treatment with two prior medicines, one of which was bortezomib. Mantle cell lymphoma is a cancer of a type of white blood cell called lymphocytes that are in the lymph nodes.

Based on the preliminary survival data recently provided to FDA from Revlimid’s manufacturer, Celgene, on July 11, 2013, patients with CLL treated with Revlimid had a 92% increased risk for death compared to patients with CLL treated with chlorambucil (34 deaths out of 210 patients in Revlimid arm vs. 18 deaths out of 211 patients in chlorambucil arm, respectively; overall survival [OS] hazard ratio [HR] 1.92; 95% confidence interval [CI] 1.08, 3.41).
FDA will communicate any new information on Revlimid and this clinical trial when it becomes available. FDA urges health care professionals and patients to report adverse events involving Revlimid to the FDA MedWatch program, using the information in the “Contact FDA” box at the bottom of the page.
Figure 1. Overall Survival curve based on the preliminary data Celgene submitted to FDA on July 11, 2013