Big study comparing old standard of chlorambucil to lenalidomide in CLL halted early because of increased deaths in lenalidomide arm. Lenalidomide unquestionably a maqjor drug in myeloma, but NOT in CLL. Bad news for CELG and good news for PCYC
Not that old a little over a month ago.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