Celgene Secures Revlimid Frontline Myeloma Approval

Labeling includes new warning for development of second primary malignancies and more language about other kinds of adverse events, but there is already widespread off-label use and analysts don’t expect the warnings to have much impact.

With strong off-label use already, even with new warnings about the risk of developing second primary malignancies, the new approval for Celgene Corp.’s oral immunomodulator Revlimid (lenalidomide) in newly diagnosed multiple myeloma – with continuous use to disease progression – should continue growth for the company’s pivotal product.

The new indication, cleared Feb. 18, satisfies a long-standing goal for the company. Revlimid was first approved in 2006 for...

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