Eisai Corporation of North America announced that the US Food and Drug Administration (FDA) has approved an efficacy supplemental biologics license application (sBLA) for Ontak (denileukin diftitox) solution for intravenous injection for the treatment of patients with persistent or recurrent cutaneous T-cell lymphoma (CTCL) whose malignant cells express the CD25 component of the interleukin (IL)-2 receptor (CD25+). A separate efficacy supplement that included data from patients with CTCL whose malignant cells did not test positive for the CD25 component of the IL-2 receptor received a complete response letter.
The details can be read here.
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