FDA Announces Revlimid Safety Review amid Secondary Cancer Concerns

Patients treated with <"http://www.yourlawyer.com/practice_areas/defective_drugs">Revlimid (lenalidomide) may be at an increased risk of developing new cancer, prompting the U.S. Food & Drug Administration (FDA) to announce a safety review of the drug. Revlimid is used in conjunction with other drugs as a treatment for multiple myeloma, as well as a blood disorder called myelodysplastic syndrome.

Since lenalidomide is an analogue of thalidomide, the FDA is also reviewing all available information on the potential secondary cancer risk for thalidomide, the agency said in Drug Safety Communication issued late Friday.

According to the FDA, the agency is aware of the results of controlled clinical trials that showed a higher rate of second primary (new) malignancies, particularly acute myelogenous leukemia (AML) and B-cell lymphoma malignancies, among patients who were treated with Revlimid compared with those who were not. Data from evaluation of outcomes after long-term treatment also showed numerous second primary malignancies.

For this reason, the FDA “is currently reviewing all available information on this potential risk and will communicate any new recommendations once it has completed its review.”

At this time, FDA recommends that patients continue their Revlimid treatment as prescribed by their healthcare provider. The benefits and the risks of Revlimid should be carefully weighed when prescribing this drug. Healthcare professionals should be aware that Revlimid may increase the risk of developing another type of cancer, the FDA said.

The FDA’s Drug Safety Communication follows the news that the European Medicines Agency had begun an investigation into Revlimid’s risks and benefits last month because of its possible link to new cancer. Like the FDA, the European regulator advised physicians and patients to continue to use Revlimid according to its approved use until its review is complete.

Revlimid, marketed by Celgene is one of the most successful blood cancer drugs on the market, with 2010 sales expected to reach $2.45 billion.

Concerns about Revlimid and secondary cancers first surfaced in December at the American Society of Hematology annual meeting when new information was presented from a study of Revlimid long-term maintenance therapy in multiple myeloma. That study reported 15 cases of secondary malignancies in Revlimid patients compared to six cases of secondary cancer in placebo patients. Another 4 cases of secondary cancer were reported in patients enrolled in the study but who had not yet been randomized to receive either Revlimid or placebo.

According to an article published by TheStreet.com at the time, those cases might have been explained away as a simple statistical anomaly except for the fact that the same trend showed up twice again during subsequent presentations at the conference of data from two other trials investigating long-term use of Revlimid.

Across three separate studies totaling about 1,060 patients, long-term Revlimid treatment was associated with 32 secondary cancers, or 5.9%, compared to 9 secondary cancers, or 1.7%, in patients treated with a placebo, TheStreet.com reported.

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