Bendeka FDA Approved for Pretreated CLL, NHL

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The FDA has approved bendamustine hydrochloride (Bendeka) injection for the treatment of chronic lymphocytic leukemia (CLL) or indolent B-cell non-Hodgkin lymphoma (NHL).

The rapid infusion formulation was granted Orphan Drug Designations for patients whose disease progressed within 6 months of treatment with rituximab or a rituximab-containing regimen.

The companies codeveloping Bendeka, Teva Pharmaceuticals and Eagle Pharmaceuticals, made the announcement of the approval. In the United States, Teva is responsible for commercialization of Bendeka. The company noted that the medication should become available during the first quarter of 2016.

“Teva looks forward to commercializing this new bendamustine product, which we believe represents an important benefit to both patients and healthcare providers,” Paul Rittman, Senior Vice President and General Manager, Teva Oncology, said in a statement. “We are pleased to add Bendeka to Teva’s Oncology portfolio, and bendamustine franchise, furthering our commitment to enhancing treatment options for patients affected by cancer.”

For patients with CLL, the approved dosing schedule for Bendeka is 100 mg/m² on days 1 and 2 of a 28-day cycle for up to 6 cycles. For NHL, the treatment was approved at a 120-mg/m² dose on days 1 and 2 of a 21-day cycle for up to 8 cycles. For patients with CLL, Bendeka was explored in an open-label study that contained 301 patients with previously untreated Stage B or C CLL. Patients were randomized to Bendeka (n = 153) or chlorambucil (n = 148). The median age of patients in the Bendeka arm was 63 versus 66 years with chlorambucil.

The overall response rate (ORR) with Bendeka was 59%, with a complete response (CR) rate of 8%. For those in the chlorambucil arm, the ORR was 26%, with a CR rate of <1%. The median progression-free survival (PFS) with Bendeka was 18 months versus 6 months with chlorambucil (HR, 0.27; 95% CI, 0.17-0.43; ^P <.0001).

For those with NHL, the efficacy was established in a single-arm study of 100 patients with indolent B-cell NHL who had not progressed during or within six months of treatment with rituximab or a rituximab-containing regimen. The median age of patients in this study was 60 years. Tumors consisted of follicular lymphoma (62%), diffuse small lymphocytic lymphoma (21%), and marginal zone lymphoma (16%).

The ORR with Bendeka was 74%, with a CR rate of 13%. The unconfirmed CR rate was 4%. The duration of response was 9.2 months (95% CI, 7.1-10.8).

During infusion, the most common adverse events (AEs) were nausea and fatigue. The most common (≥15%) hematologic abnormalities associated with Bendeka during the trial were lymphopenia, anemia, leukopenia, thrombocytopenia, and neutropenia.

The most common hematologic AEs associated with Bendeka for patients with CLL were pyrexia, nausea, and vomiting. For those with NHL, the most common non-hematologic AEs were nausea, fatigue, vomiting, diarrhea, pyrexia, constipation, anorexia, cough, headache, weight decreased, dyspnea, rash, and stomatitis.

Bendeka is contraindicated for patients with a history of a hypersensitivity reaction to bendamustine, including anaphylaxis and anaphylactoid reactions. Additionally, the agent should not be used for those with hypersensitivity to polyethylene glycol 400 or propylene glycol.

“We are thrilled that the FDA has approved Bendeka and are excited for what we believe will be a promising launch with Teva," Scott Tarriff, President and Chief Executive Officer of Eagle Pharmaceuticals, said in a statement. "Importantly, we believe that patients with CLL or indolent B-cell NHL that has progressed will benefit from the multiple administration options this product offers.”