FDA Fast Track Designation for BI-1808 to Treat Cutaneous T-cell Lymphoma
“Receiving FDA’s Fast Track Designation following the recent Orphan Drug Designation underscores the potential of this novel immunomodulatory agent and reflects the urgent need for new, safe and durable treatment options for patients with CTCL”, said Martin Welschof, Chief Executive Officer of BioInvent. “It’s very encouraging that the FDA confirms that the presented BI-1808 data meet expectations to address this important unmet medical need”. To date, BI-1808 demonstrated early clinical efficacy in heavily pretreated patients with an excellent safety and tolerability profile. We are committed to continue advancing the development of BI-1808 and look forward to providing an update from the ongoing Phase 2a by mid-2025.”
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