Agency recommends updating prescribing information for Revlimid and warning doctors of risks to patients.

EMA’s Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of Celgene’s multiple myeloma drug Revlimid® (lenalidomide) do outweigh risk in its currently approved patient population, even though use of the drug is associated with an increased risk of new cancers developing. The committee’s opinion has been forwarded to the European Commission for the adoption of a decision.

The EMA’s Article 20 review had been carried out following data from three new studies in newly diagnosed multiple myeloma patients, which showed that Revlimid therapy was associated with a four-fold increase in the number of secondary primary malignancies developing, including solid tumors and blood or immune system cancers. Although Revlimid has yet to be approved in this patient population, EMA carried out a review to weigh the benefits of Revlimid against its risks in multiple myeloma patients who have already received one prior therapy, which is the approved population.

The review encompassed all available data on new cancers in the approved population, including results from clinical studies and postmarketing data. It concluded that the risk of new cancers including  skin cancers and some invasive solid tumors was observed in the approved population.

Nevertheless, CHMP decided that “the benefits of Revlimid, particularly improved survival, continue to outweigh the risks”.  It has recommended that the prescribing information for Revlimid be updated with a warning, and doctors are advised on the risk of new cancers developing in treated patients.

FDA started its review of Revlimid (and thalidomide, to which lenalidomide is related) back in April, when it put out a public notice warning that trials had linked the drug with the development of new types of cancer. At the time, the agency stated that there was “no recommendation to delay, modify, or restrict the use of Revlimid for patients being treated according to the FDA-approved indication.” It stated that until the review was complete, the agency continued to believe that  “the benefits of Revlimid continue to outweigh the potential risks.”

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