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Bristol Basks In Broad Ipilimumab Label, Sets High Price

This article was originally published in The Pink Sheet Daily

Executive Summary

Labeling does not specify line of therapy, so the melanoma drug could see use beyond very late-stage refractory patient population studied in pivotal trial.

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FDA’s Oncologic Drugs Advisory Committee will review the drug/device combination for treatment of patients with unresectable ocular melanoma that is metastatic to the liver. The system, which uses the chemotherapy drug melphalan, has shown significant improvement in hepatic progression-free survival.

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