Maxim Withdraws Ceplene Advanced Malignant Melanoma NDA
This article was originally published in The Pink Sheet Daily
Executive Summary
The company is shifting its focus for Ceplene to acute myeloid leukemia. Melanoma patients enrolled in the confirmatory Phase III trial will be allowed to complete their treatment regimen under a compassionate use program.
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Maxim Seeks Ceplene Development Partner After FDA Request For More Data
FDA indicates that approval of Ceplene for the treatment of acute myeloid leukemia would require confirmatory Phase III trial, Maxim says. The company previously withdrew an NDA for use of the oncologic in advanced malignant melanoma.
Maxim Seeks Ceplene Development Partner After FDA Request For More Data
FDA indicates that approval of Ceplene for the treatment of acute myeloid leukemia would require confirmatory Phase III trial, Maxim says. The company previously withdrew an NDA for use of the oncologic in advanced malignant melanoma.
Maxim's Ceplene Fails Trial In Advanced Malignant Melanoma
Company will continue to pursue approval for acute myeloid leukemia indication. Maxim plans to review its pipeline, operations and resources to focus on advancing Ceplene and other products to market.