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12:00 AM
May 16, 2011
 |  BioCentury  |  Product Development

Quelling Qualms about Revlimid

Revlimid's survival data trumps secondary cancer risk in maintenance setting

Updated Phase III data on the use of Celgene Corp.'s Revlimid lenalidomide as maintenance therapy in multiple myeloma have quelled fears that the risk of second primary malignancies might outweigh the drug's survival benefit.

Questions about a possible association between Revlimid and second primary malignancies (SPMs) first cropped up at the American Society of Hematology meeting in December. The observations came from three ongoing Phase III trials in which higher rates of SPMs were seen in patients receiving Revlimid vs. those given placebo as maintenance therapy.

While all three studies had met their primary endpoints - progression-free survival (PFS) in two cases and time to disease progression in one - the red flag aroused some anxiety.

At the time, the company said SPMs were seen in 6.5% of Revlimid patients and 2.6% of placebo patients in the CALGB-100104 trial in 460 transplant patients. A second study (IFM 2005...

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