FDA approved Bendeka (bendamustine hydrochloride) injection, a 10-minute infusion formulation of bendamustine.
Bendeka is approved for the treatment of patients with chronic lymphocytic leukemia and for the treatment of patients with indolent B-cell non-Hodgkin lymphoma that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen. Efficacy relative to first line CLL therapies other than chlorambucil has not been established.
Bendeka is contraindicated in patients with a known hypersensitivity (e.g., anaphylactic and anaphylactoid reactions) to bendamustine. Bendeka is also contraindicated in patients with a known hypersensitivity to polyethylene glycol 400, propylene glycol, or monothioglycerol.
Bendamustine hydrochloridecaused severe myelosuppression in 98% of patients in the two NHL studies. Three patients (2%) died from myelosuppression-related adverse reactions.
Teva Pharmaceuticals, the sponsor, expects to make Bendeka available to patients in the first quarter of 2016. Bendeka was granted Orphan Drug Designations for both CLL and indolent B-cell NHL.
