Summary

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• Lumoxiti (moxetumomab pasudotox-tdfk) is indicated for the treatment of adult patients with relapsed or refractory hairy cell leukemia (HCL) who received at least two prior systemic therapies, including treatment with a purine nucleoside analog (PNA).
• This summary is based on the review of five systematic review(s)/meta-analysis(es). ^[1-5]
• Vemurafenib (Monotherapy and Combination with Rituximab): In the US arm, monotherapy with vemurafenib showed an Overall Response Rate (ORR) of 100%, with a Complete Response (CR) rate of 42% and a Partial Response (PR) rate of 58%. In the Italian arm, the ORR was 96%, with a CR rate of 35% and a PR rate of 62%. When combined with rituximab, the CR rate was 100%.
• Bendamustine/Rituximab (BR): For the 70 mg/m² dose of bendamustine/rituximab, the ORR was 100% with a CR rate of 50%. At the 90 mg/m² dose, the ORR remained 100%, with a CR rate of 67%.
• Moxetumomab Pasudotox: In a Phase 3 trial involving 80 participants, moxetumomab pasudotox had an ORR of 75% with a CR rate of 41%. Common adverse reactions include infusion-related reactions, edema, nausea, fatigue, headache, pyrexia, and anemia. Serious adverse events reported are capillary leak syndrome and hemolytic uremic syndrome. Increased creatinine and grade ≥3 adverse events were linked to higher drug exposure.
• Vemurafenib, Rituximab, Bendamustine/Rituximab, Ibrutinib: Generally well-tolerated.
• There is no population types or subgroups information available in the reviewed studies.