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U.S. Department of Health and Human Services

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Bendamustine Hydrochloride

On October 31, 2008, the Food and Drug Administration (FDA) approved bendamustine hydrochloride (TREANDA, Cephalon, Inc.), an intravenously administered alkylating agent, for the treatment of patients with indolent B-cell non-Hodgkin’s lymphoma (NHL) that progressed during or within 6 months of treatment with rituximab or a rituximab-containing regimen.

Bendamustine hydrochloride was evaluated in a single arm trial of 100 patients with indolent B-cell NHL. All patients had disease progression during or within six months of treatment with rituximab or a rituximab-containing regimen. Bendamustine hydrochloride was administered intravenously at a dose of 120 mg/m 2 infused over 60 minutes on days 1 and 2 of a 21-day treatment cycle for up to 8 cycles.  

Efficacy was assessed by a blinded independent review committee using the modified International Working Group response criteria for NHL.  The efficacy endpoints included overall response rate (complete responses, complete responses unconfirmed, or partial responses) and durations of response (DR).  ORR and median DR were 74% (95% CI 64.3, 82.3) and 9.2 months (95% CI 7.1, 10.8), respectively. Complete responses were reported in 13%, complete responses unconfirmed in 4%, and partial responses in 57% of patients treated.

The safety of bendamustine hydrochloride was evaluated in the above study and an additional study. A total of 176 patients with B-cell NHL who had received prior rituximab (161 patients with indolent lymphoma and 15 with transformed NHL) were evaluated for safety.

The most frequently reported non-hematologic adverse reactions reported were nausea (75%), fatigue (57%), vomiting (40%), diarrhea (37%) and pyrexia (34%).  The most frequently reported abnormal hematologic laboratory values were lymphopenia (99%), leukopenia (94%), anemia (88%), neutropenia (86%), and thrombocytopenia (86%).

Grade 3 or 4 adverse reactions were reported in 71% of the combined safety population.  The most frequently reported non-hematologic Grade 3 or 4 adverse reactions were fatigue (11%), febrile neutropenia (6%), and pneumonia, hypokalemia and dehydration (each reported in 5% of patients).  The most frequently reported grade 3 or 4 hematologic laboratory abnormalities were lymphocytopenia (94%), neutropenia (60%), leukopenia (56%), thrombocytopenia (25%), and anemia (11%).  Three patients died from myelosuppression-related adverse reactions; one each from neutropenic sepsis, diffuse alveolar hemorrhage with grade 3 thrombocytopenia, and pneumonia from a cytomegalovirus infection.

For patients with indolent NHL, bendamustine hydrochloride is administered as a 60 minute IV infusion on days 1 and 2 of a 21-day cycle for up to 8 cycles. The recommended dose is 120 mg/m 2 .

This dose, infusion duration, and cycle length of bendamustine hydrochloride is different from that approved dosing regimen for the chronic lymphocytic leukemia (CLL) indication.  For patients with CLL, bendamustine hydrochloride is administered as a 30 minute IV infusion on days 1 and 2 of a 28-day cycle for up to 6 cycles. The recommended dose for the CLL indication is 100 mg/m 2.

Full prescribing information, including clinical trial information, safety, dosing, drug-drug interactions and contraindications is available at Drugs@FDA          

 

 

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Date created: November 10, 2008