FDA: Celgene Drug Revlimid Increases Risk Of Certain New Cancers

By Jennifer Corbett Dooren, Of DOW JONES NEWSWIRES

WASHINGTON -(Dow Jones)- The Food and Drug Administration said certain patients treated with Celgene Corp.'s (CELG) cancer drug Revlimid have an increased risk of developing some new types of cancers.

Revlimid is approved to treat patients with multiple myeloma, a bone-marrow cancer in combination with another drug. The product is also approved to treat another bone-marrow condition called myelodysplastic syndromes.

In a drug-safety communication posted to the FDA's website Monday, the agency said data from clinical trials of Revlimid showed newly diagnosed patients treated with Revlimid had an increased risk of developing second types of cancer compared to similar patients who received a placebo, or fake drug. The agency said there was an increased risk of developing acute myelogenous leukemia, a type of blood cancer, myelodysplastic syndromes and Hodgkin lymphoma.

The FDA said the information has been added to Revlimid's label, which is aimed at giving information about products to doctors, and that patient information is being updated.

The FDA said doctors "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 with concerns should contact their doctors.

One analysis looked at three studies of patients with newly diagnosed multiple myeloma who received initial chemotherapy or chemotherapy and blood-stem-cell transplantation followed by treatment with Revlimid or a placebo. The FDA said there were 65 second primary malignancies, or cancer, among 824 patients in the Revlimid treatment arms, compared to 19 second primary malignancies among 665 patients in the treatment arms that didn't include Revlimid.

-By Jennifer Corbett Dooren; Dow Jones Newswires, 202-862-9294; jennifer.corbett@dowjones.com

Link:
FDA: Celgene Drug Revlimid Increases Risk Of Certain New Cancers