Delcath Sticks With Melblez Chemosaturation But Dumps CEO On FDA Rebuff
This article was originally published in The Pink Sheet Daily
FDA’s “complete response” letter requesting further studies is no surprise after a scathing ODAC assessment in May, but with an interim CEO team in place, the company says it’s ready to work things out with regulators.
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Accrual difficulties force changes that nullify Special Protocol Assessment; ongoing, randomized FOCUS trial in patients with ocular melanoma that has metastasized to liver will become single-arm study and target enrollment will be reduced by 66%.
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.
Commercialization of the fixed-dose combo buys lifecycle management for Forest and should support future drug development for partner Adamas, the originator of the technology behind the combination.