Bristol Basks In Broad Ipilimumab Label, Sets High Price
This article was originally published in The Pink Sheet Daily
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.
Vindicated by the approvals of Provenge and Yervoy, a host of therapeutic cancer vaccines is working through late-stage trials with the regulatory finish line in sight, and some of those companies will be presenting data at the American Society of Clinical Oncology meeting in Chicago June 1-5.
No longer the odd cousins of traditional pharmaceutical applications, a host of therapeutic cancer vaccines is working through late-stage trials with real, life-extending data already reported and the potential to create a lot of action in the oncology sector.