FDA Sets Action Date for Resubmitted Lymphir in Rare Skin Cancer.

SKIN tumors; RARE diseases; FATIGUE (Physiology); EDEMA; UNITED States. Food & Drug Administration; CUTANEOUS T-cell lymphoma; AMERICAN Cancer Society Inc.; PHYSICIAN practice patterns; DIPHTHERIA; DRUG prescribing; NAUSEA

The article focuses on the Food and Drug Administration's acceptance of Citius Pharmaceuticals' resubmitted biologics license application for Lymphir, intended for patients with relapsed or refractory cutaneous T-cell lymphoma, setting an action date of Aug. 13, 2024. Topics include the mechanism of Lymphir, its previous marketing history, and the pivotal phase 3 study supporting its efficacy, which demonstrated disease control and an objective response rate, with common adverse events noted.