Oncology

FDA grants fast-track designation for metastatic melanoma treatment

Published in Women's Health Weekly, November 4th, 2004

Medarex (MEDX) announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for Medarex's fully human antibody against human CTLA-4, MDX-010 in combination with MDX-1379, a melanoma vaccine, for the treatment of previously treated, unresectable Stage III and Stage IV metastatic melanoma.

Medarex is currently conducting a Phase III clinical trial with MDX-010 and MDX-1379 combination therapy in Stage III and IV melanoma at multiple sites within the United States. In this trial, approximately 750 patients with previously treated Stage III or Stage IV metastatic melanoma are expected to be enrolled. The patients will be randomized to...

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Source: Women's Health Weekly (2004-11-04)

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