Citius Oncology, Inc. (NASDAQ: CTOR) announced the commercial launch of LYMPHIR (denileukin diftitox-cxdl), a cancer immunotherapy approved by the U.S. Food and Drug Administration for treating adult patients with relapsed or refractory Stage I-III cutaneous T-cell lymphoma after at least one prior systemic therapy.
The FDA approval was based on data from Pivotal Study 302, which demonstrated an objective response rate of 36.2%, with 84% of evaluable patients experiencing a reduction in skin tumor burden. The median time to response was 1.4 months. The study showed LYMPHIR demonstrated activity on severe pruritus, a significant quality of life issue for CTCL patients.
LYMPHIR is now available through specialty distributors nationwide and has been assigned a permanent J-code (J9161), effective April 1, 2025, to facilitate reimbursement. The product has been included in the National Comprehensive Cancer Network Guidelines for CTCL with a Category 2A recommendation.
Cutaneous T-cell lymphoma is a type of non-Hodgkin lymphoma where T-cells become cancerous and develop into skin lesions. The disease affects men twice as often as women and is typically diagnosed in patients between ages 50 and 60.
Citius Oncology holds exclusive rights to develop and commercialize LYMPHIR in all global markets except India, Japan, and certain parts of Asia. The company recently announced a distribution agreement with Integris Pharma S.A. to initiate named-patient access programs in Greece, Cyprus, and other Southern European and Balkan countries.
LYMPHIR carries a boxed warning for capillary leak syndrome, which can be life-threatening. In clinical trials, capillary leak syndrome occurred in 27% of patients, including 8% with Grade 3 severity. Other common adverse reactions include increased transaminases, decreased albumin, nausea, edema, decreased hemoglobin, fatigue, musculoskeletal pain, rash, chills, constipation, and fever.
Citius Oncology is the oncology-focused subsidiary of Citius Pharmaceuticals, Inc. (NASDAQ: CTXR), which owns 79% of the company.
No comments:
Post a Comment
Note: Only a member of this blog may post a comment.