FDA Approves Beleodaq to Treat Rare, Aggressive Form of Non-Hodgkin Lymphoma

The Food and Drug Administration July 3 approved Beleodaq (belinostat) for the treatment of patients with peripheral T-cell lymphoma (PTCL), a rare and fast-growing type of non-Hodgkin lymphoma (NHL).

The FDA said this action was taken under its accelerated approval program, which allows for approval of a drug based on surrogate or intermediate endpoints reasonably likely to predict clinical benefit for patients with serious conditions with unmet medical needs.

Drugs receiving accelerated approval are subject to confirmatory trials verifying clinical benefit, the agency said. Beleodaq, which is marketed by Henderson, Nev.-based Spectrum Pharmaceuticals Inc., also received orphan product designation by ...