Eisai Corporation of North America announced today that the US Food and Drug Administration (FDA) has accepted for priority review a supplemental biologics license application (sBLA) for denileukin diftitox (Ontak). The sBLA seeks to convert an accelerated approval indication into full approval. It is based on a placebo-controlled phase III clinical trial to confirm the clinical effectiveness of the drug in certain patients with cutaneous T-cell lymphoma (CTCL).
Denileukin diftitox is indicated for the treatment of patients with persistent or recurrent CTCL whose malignant cells express the CD25 component of the interleukin (IL)-2 receptor. The safety and efficacy of the agent in patients with CTCL whose malignant cells do not express the CD25 component of the IL-2 receptor have not been examined. Denileukin diftitox was granted accelerated approval under subpart E in February 1999.
Subpart E is an FDA regulation that allows the accelerated approval of a biologic agent based on a surrogate endpoint or an effect on a clinical endpoint other than survival and is most common in serious diseases or for medications that fill an unmet medical need. All subpart E approvals are contingent on the completion of postmarketing clinical trials that confirm a clinical benefit of the biologic agent.