TREANDA for Injection is indicated for treatment of patients with indolent B-cell non-Hodgkin's lymphoma (NHL) that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen.
TREANDA produced an overall response rate of 74% with a median duration of response of 9.2 months
Trial Design
A multicenter, single-arm trial including 100 patients. Patients received TREANDA 120 mg/m2 on Days 1 and 2 of a 21-day treatment cycle, for up to 8 cycles. Efficacy endpoints included overall response rate (ORR)† and duration of response (DR).
Patients with indolent B-cell NHL that progressed during or following treatment with rituximab or a rituximab-containing regimen were included if they relapsed within 6 months of either the first (monotherapy) or last dose (maintenance regimen or combination therapy) of rituximab.
†ORR was defined as a best response of a complete response (CR), unconfirmed complete response (CRu), or partial response (PR) during the study (ORR=CR+CRu+PR).
Safety profile
- Most common non-hematologic adverse reactions for NHL (frequency >15%) are nausea (75%), fatigue (57%), vomiting (40%), diarrhea (37%), pyrexia (34%), constipation (29%), anorexia (23%), cough (22%), headache (21%), weight decreased (18%), dyspnea (16%), rash (16%), and stomatitis (15%).
- Most common hematologic abnormalities for NHL (frequency >15%) are lymphopenia (99%), leukopenia (94%), anemia (88%), thrombocytopenia (86%), and neutropenia (86%).
- Patients receiving TREANDA experienced low incidence of alopecia.
Please see the full Prescribing Information.