The US FDA Approves Citius Pharmaceuticals’ Lymphir to Treat R/R Cutaneous T-Cell Lymphoma (CTCL)
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- The US FDA has granted approval to Lymphir for treating chronic r/r CTCL in patients treated with at least one prior systemic therapy, with its introduction anticipated within the next 5mos.
- The approval was based on P-III (Study 302) trial assessing the safety & efficacy of Lymphir (9mcg/kg, IV) among patients (n=69) with r/r CTCL (stage I to IV)
- The study showed an ORR of 36.2%, CR in 8.7%, median time to response of 1.41mos. in ~70% post 1–2 cycles of treatment and DoR of at least 6mos. in 52%. 84.4% of them showed reduced skin tumor burden, with 12.5% achieving complete skin clearance. Pruritus improved in 31.7% of patients without any cumulative toxicity
Ref: Citius Pharmaceuticals | Image: Citius Pharmaceuticals
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A passionate content writer with expertise in delivering high-quality and engaging content, Dipanshu is a keen reader and a versatile writer. Dipanshu dedicatedly covers news ranging from biopharma, life sciences, biotech, and MedTech to diagnostics and animal health companies, FDA, EMA, and biosimilar approvals. He can be contacted at connect@pharmashots.com
