• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Drugs

  • Print
  • Share
  • E-mail

FDA Drug Safety Communication: Safety review update of cancer drug Revlimid (lenalidomide) and risk of developing new types of malignancies

(en Español)

This update is in follow-up to the FDA Drug Safety Communication: Ongoing safety review of Revlimid (lenalidomide) and possible increased risk of developing new malignancies.

Safety Announcement
Additional Information for Patients
Additional Information for Healthcare Professionals
Data Summary
 

Safety Announcement

Facts about Revlimid (lenalidomide)

  • Prescription medicine approved in combination with dexamethasone to treat patients with multiple myeloma (a type of cancer of the bone marrow) who already have had prior therapy
  • Also approved to treat certain patients who have certain types of myelodysplastic syndromes (a group of conditions in which the bone marrow does not produce enough mature blood cells)
 

[5-07-2012] The U.S. Food and Drug Administration (FDA) is informing the public of an increased risk of second primary malignancies (new types of cancer) in patients with newly-diagnosed multiple myeloma who received Revlimid (lenalidomide). Clinical trials conducted after Revlimid was approved showed that newly-diagnosed patients treated with Revlimid had an increased risk of developing second primary malignancies compared to similar patients who received a placebo. Specifically, these trials showed there was an increased risk of developing acute myelogenous leukemia, myelodysplastic syndromes, and Hodgkin lymphoma.

This safety information has been added to the Warnings and Precautions section of the Revlimid drug label. The patient Medication Guide is also being updated to inform patients about this risk.

Healthcare professionals should consider both the potential benefit of Revlimid and the risk of second primary malignancies when deciding to treat patients with this drug, and monitor patients for this risk.

Patients should contact their healthcare professional if they have any questions or concerns about Revlimid.

In April 2011, FDA announced an ongoing safety review to evaluate the possible increased risk of second primary malignancies with Revlimid. FDA performed a comprehensive review of this safety issue (see Data Summary below).

Additional Information for Patients

  • Know that, in clinical trials of patients newly diagnosed with multiple myeloma, those patients treated with Revlimid had an increased risk of developing new cancers, particularly, acute myelogenous leukemia, myelodysplastic syndromes, and Hodgkin lymphoma, compared to patients receiving a placebo.
  • Contact your healthcare professional if you have any questions or concerns about Revlimid.
  • Read the Medication Guide that comes along with your Revlimid prescription.
  • Report side effects from Revlimid to the FDA MedWatch program, using the information in the "Contact FDA" box at the bottom of this page.
     

Additional Information for Healthcare Professionals 

  • Know that, in clinical trials of patients newly diagnosed with multiple myeloma, those patients treated with Revlimid had an increased risk of developing second primary malignancies, particularly, acute myelogenous leukemia, myelodysplastic syndromes, and Hodgkin lymphoma, compared to patients receiving a placebo.
  • Monitor patients taking Revlimid for the development of second primary malignancies.
  • Take into account both the potential benefit of Revlimid and the risk of second primary malignancies when considering treatment with Revlimid.
  • Encourage patients to read the Medication Guide when they receive their Revlimid prescription.
  • Please continue to report adverse events involving Revlimid to the FDA MedWatch program using the information in the "Contact FDA" box at the bottom of this page.
     

Data Summary

FDA reviewed controlled clinical trials of Revlimid as maintenance therapy in patients with newly-diagnosed multiple myeloma and for the treatment of relapsed/refractory multiple myeloma, to evaluate the risk of developing a second primary malignancy with Revlimid.

Second primary malignancies in patients with newly diagnosed multiple myeloma

In three prospective, randomized trials, patients with newly-diagnosed multiple myeloma received initial chemotherapy or chemotherapy plus blood stem cell transplantation followed by treatment with Revlimid or a placebo. This treatment protocol was used to study the effect of Revlimid as maintenance therapy. A pooled analysis of the three ongoing trials, as of February 28, 2011, showed 65 second primary malignancies among 824 patients in the Revlimid treatment arms compared to 19 second primary malignancies among 665 patients in the treatment arms that did not include Revlimid maintenance (7.9% vs. 2.8%; p<0.001). This difference is almost a three-fold increase in new malignancies for the groups receiving Revlimid versus the groups that did not receive Revlimid. The second primary malignancies noted included acute myelogenous leukemia (AML), myelodysplastic syndromes (MDS), and B-cell malignancies. Overall, 30 (3.6%) second primary hematologic malignancies were reported in the Revlimid treatment arms (22 MDS/AML, 5 Hodgkin lymphoma, 3 B-cell acute lymphoblastic leukemia) compared with 2 (0.3%) cases of AML in the study arms not receiving Revlimid. The median time from start of Revlimid to a diagnosis of a second primary malignancy was two years. Based on the available data, there appears to be no difference in the incidence of non-melanoma skin cancers or of solid tumors between the patients who received Revlimid and those who did not.

Second primary malignancies in patients with relapsed/refractory multiple myeloma

A retrospective pooled analysis of second primary malignancies also was conducted on data derived from the two clinical trials that supported the initial FDA approval for relapsed multiple myeloma. These were multicenter, double-blind, placebo-controlled, parallel-group trials of Revlimid plus high-dose dexamethasone therapy versus dexamethasone alone in the treatment of patients with relapsed or refractory multiple myeloma. The incidence rates of developing a second primary malignancy during the treatment phase of these trials were 3.98 and 1.38 per 100 person-years for patients in the Revlimid/dexamethasone and the placebo/dexamethasone groups, respectively. The higher incidence rate of second primary malignancies in the Revlimid/dexamethasone group was largely accounted for by the higher incidence of non-melanoma skin cancers with Revlimid (2.4 vs. 0.91 per 100 person-years for the Revlimid/dexamethasone and placebo/dexamethasone groups, respectively). The patients in the Revlimid/dexamethasone group had longer on-study treatment time compared to the placebo/dexamethasone group (467 person-years vs. 218.7 person-years, respectively). When adjusted for the differences in observation time on-study, the incidence rate of invasive non-melanoma skin cancers was not substantially different between the two groups (1.71 vs. 0.91 per 100 person-years, respectively).

 

Contact FDA

1-800-332-1088
1-800-FDA-0178 Fax
Report a Serious Problem

MedWatch Online

Regular Mail: Use postage-paid FDA Form 3500

Mail to: MedWatch 5600 Fishers Lane

Rockville, MD 20857