The US Food and Drug Administration (FDA) has approved the use of Velcade for the retreatment of myeloma patients who have previously responded to Velcade treatment and relapsed at least six months following completion of prior Velcade treatment. The approval is based on the results of the Phase II RETRIEVE trial which showed an overall response rate of 38.5% in patients who were previously treated with Velcade (median of two prior lines) and had previously achieved a partial response or better. The labelling update includes dosing guidelines as well as safety and efficacy findings for the use of Velcade as a monotherapy or in combination with dexamethasone, in this patient group.

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