I/ONTAK filed with FDA for cutaneous T-cell lymphoma
Citius Pharmaceuticals announced that the Company has submitted a Biologics License Application (BLA) to the FDA for I/ONTAK (denileukin diftitox), an engineered IL-2-diphtheria toxin fusion protein for the treatment of patients with persistent or recurrent cutaneous T-cell lymphoma (CTCL)
I/ONTAK is a purified and more bioactive formulation of previously FDA-approved ONTAK. The BLA is supported by a pivotal Phase III study (NCT01871727). Results of the study were consistent with the prior FDA-approved formulation.
ONTAK was marketed in the U.S. from 1999 to 2014, when it was voluntarily withdrawn from the market. Manufacturing improvements resulted in a new formulation, which maintains the same amino acid sequence but features improved purity and bioactivity. The new formulation received regulatory approval in Japan in 2021 for the treatment of CTCL and peripheral T-cell lymphoma (PTCL). In 2011 and 2013, the FDA granted orphan drug designation (ODD) to I/ONTAK for the treatment of PTCL and CTCL, respectively.
Learning Zones
The Learning Zones are an educational resource for healthcare professionals that provide medical information on the epidemiology, pathophysiology and burden of disease, as well as diagnostic techniques and treatment regimens.
2 mins