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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