Phase 2 and 3 studies of Zevalin for the treatment of non-Hodgkin's lymphoma (NHL)

Spectrum Pharmaceuticals announced results from both a Phase 2 and Phase 3 study of Zevalin (ibritumomab tiuxetan) injection for the treatment of follicular non-Hodgkin's lymphoma (NHL). Spectrum reported early positive results from the first Phase 2 clinical trial evaluating treatment-naïve patients with follicular NHL treated with Zevalin injection for intravenous use as a monotherapy. This trial differed from earlier Zevalin trials in NHL in that patients were treated with Zevalin first-line, without the use of upfront chemotherapy. The preliminary results from this 60-patient, single-arm study show that treatment-naïve patients who received a single dose of Zevalin alone achieved a one-year overall clinical response rate of 84% (53% complete response and 31% partial response).

The Phase 3 trial demonstrated that after a median follow-up of 66.2 months, patients with previously untreated follicular NHL treated with a standard, single-dose infusion of Zevalin as part of the Zevalin Therapeutic Regimen after partial or complete response to first-line chemotherapy had a nearly three-year advantage in median progression-free survival (PFS) compared to patients treated with either chemotherapy alone or chemotherapy plus rituximab (49 months versus 14 months).

Zevalin is a CD20-directed radiotherapeutic antibody indicated for the treatment of patients with previously untreated follicular non-Hodgkin's lymphoma (NHL), who achieve a partial or complete response to first-line chemotherapy. Zevalin is also indicated for the treatment of patients with relapsed or refractory, low-grade or follicular B-cell non-Hodgkin's lymphoma.

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