Bendamustine hydrochloride (TREAKISYM®) has been approved in Japan as first-line treatment for patients with low-grade B-cell non-Hodgkin lymphoma (NHL) and mantle cell lymphoma (MCL).
The drug will now be available for adjunctive use with rituximab in these patients.
Bendamustine hydrochloride is already approved in Japan as monotherapy for relapsed or refractory low-grade B-cell NHL and MCL, as well as chronic lymphocytic leukemia.
Bendamustine hydrochloride is the subject of a licensing agreement concluded between Eisai Co., Ltd and SymBio Pharmaceuticals Limited. Under the licensing agreement, Eisai has been marketing the product since December 2010.
Bendamustine hydrochloride is available at doses of 25 mg and 100 mg for intravenous infusion. The recommended dosage and administration is as follows:
- For low-grade B-cell NHL and MCL
- As first-line treatment
When used adjunctively with rituximab, the usual adult dose of bendamustine hydrochloride is 90 mg/m2 body surface area infused intravenously over 60 minutes on days 1 and 2 of repeated 28-day cycles.
- For relapsed or refractory disease
The usual adult dose of bendamustine hydrochloride is 120 mg/m2 body surface area infused intravenously over 60 minutes on days 1 and 2 of repeated 21-day cycles.
- As first-line treatment
- For chronic lymphocytic leukemia
- The usual adult dose of bendamustine hydrochloride is 100 mg/m2 body surface area infused intravenously over 60 minutes on days 1 and 2 of repeated 28-day cycles.
All of the aforementioned doses may be reduced appropriately according to the patient’s condition.
