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FDA Approves Maintenance Lenalidomide for Myeloma

FDAThe FDA has approved lenalidomide (Revlimid) as a maintenance therapy for patients with multiple myeloma following autologous hematopoietic stem cell transplant (auto-HSCT), according to Celgene, the manufacturer of the treatment.

In the study, which was presented at the 2016 ESMO Annual Meeting, the objective response rate (ORR) was 19.6% for nivolumab in patients with platinum-refractory metastatic urothelial carcinoma. The complete response rate was 3%. Across the 270-patient study, the median progression-free survival (PFS) was 2.0 months and the median overall survival (OS) was 8.74 months.

The data for the approval came from 2 large trials (1000+ patients each) that compared maintenance lenalidomide versus no maintenance after auto-HSCT. The primary endpoint of both studies was progression-free survival (PFS).

In CALGB 100104, the median PFS was 5.7 years (95% CI, 4.4-not estimable) with lenalidomide maintenance versus 1.9 years (95% CI,1.6-2.5) for no maintenance, representing a 3.8-year benefit (HR, 0.38; 95% CI, 0.28-0.50). In the IFM 2005-02 trial, the median PFS was 3.9 years (95% CI, 3.3-4.7) versus 2 years (95% CI, 1.8-2.3), respectively, representing a 1.9-year benefit (HR, 0.53; 95% CI, 0.44-0.64). Click here to read the full article at

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