The U.S. Food and Drug Administration has approved Bendeka (bendamustine hydrochloride) injection for the treatment of patients with chronic lymphocytic leukemia (CLL) and indolent, B-cell non-Hodgkin lymphoma (NHL) that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen. Bendeka is a liquid, low-volume and short-time 10-minute infusion formulation of bendamustine.
Safety and Efficacy
The safety and efficacy for Bendeka for the indication in CLL have been evaluated in an open-label, randomized, controlled multicenter trial of 301 previously-untreated patients with Binet Stage B or C (Rai Stages I-IV) CLL requiring treatment. Need-to-treat criteria included hematopoietic insufficiency, B-symptoms, rapidly progressive disease, or risk of complications from bulky lymphadenopathy. Patients with autoimmune hemolytic anemia or autoimmune thrombocytopenia, Richter's syndrome, or transformation to prolymphocytic leukemia were excluded from the study. Patients received Bendeka or chlorambucil. The available data showed a higher overall response rate (90% vs. 38%) and a longer progression-free survival rate for the patients receiving Bendeka compared with patients receiving chlorambucil, though survival data are not yet mature, according to the prescribing information from the drug company developing the agent, Teva Pharmaceuticals.
The efficacy for Bendeka for the indication in NHL has been evaluated in a single arm study of 100 patients with indolent B-cell NHL that had progressed during or within six months of treatment with rituximab or a rituximab-containing regimen. Efficacy was based on the assessments by a blinded independent review committee (IRC) and included overall response rate (complete response plus complete response unconfirmed plus partial response, which was 74%) and duration of response (median duration of response was 9.2 months).
Adverse Reactions
The most common non-hematologic adverse reactions reported by patients receiving Bendeka for the treatment of CLL are pyrexia, nausea, and vomiting. The most common non-hematologic reactions reported by patients receiving Bendeka for the treatment of NHL are nausea, fatigue, vomiting, diarrhea, pyrexia, constipation, anorexia, cough, headache, weight decrease, dyspnea, rash, and stomatitis. The most common hematologic abnormalities for both indications are lymphopenia, anemia, leukopenia, thrombocytopenia, and neutropenia. Serious adverse reactions reported for patients receiving Bendeka are myelosuppression, infections, anaphylaxis and infusion reactions, tumor lysis syndrome, skin reactions, extravasation injury, and other malignancies (including myelodysplastic syndrome, myeloproliferative disorders, acute myeloid leukemia, and bronchial carcinoma, though the association with Bendeka has not been determined).
Contraindications
Bendeka is contraindicated in patients with a known hypersensitivity to bendamustine, as well as in patients with a known hypersensitivity to polyethylene glycol 400, propylene glycol, or monothioglycerol.
Clinical Quick Facts
Drug: Bendeka (bendamustine hydrochloride) injection
Approved Indication: Treatment of patients with chronic lymphocytic leukemia (CLL) and indolent, B-cell non-Hodgkin lymphoma (NHL) that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen
Serious Side Effects: Myelosuppression, infections, anaphylaxis and infusion reactions, tumor lysis syndrome, skin reactions, extravasation injury, and other malignancies (including myelodysplastic syndrome, myeloproliferative disorders, acute myeloid leukemia, and bronchial carcinoma, though the association with Bendeka has not been determined)
Common Side Effects: Pyrexia, nausea, and vomiting (for patients with CLL); nausea, fatigue, vomiting, diarrhea, pyrexia, constipation, anorexia, cough, headache, weight decrease, dyspnea, rash, and stomatitis (for patients with NHL); and lymphopenia, anemia, leukopenia, thrombocytopenia, and neutropenia (for both indications)