Citius Pharma: FDA accepts BLA resubmission for LYMPHIR (CTCL); PDUFA Aug 13, 2024

Citius Pharmaceuticals, Inc.

FDA accepted BLA resubmission for LYMPHIR (denileukin diftitox) to treat relapsed/refractory cutaneous T-cell lymphoma.
PDUFA target action date set for August 13, 2024.
Resubmission addresses July 2023 CRL; no safety or efficacy issues cited, no additional trials required.
BLA supported by pivotal Phase 3 study (NCT01871727).

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