dm+d

Unassigned

New Medicines

I/ONTAK Persistent or recurrent cutaneous T-cell lymphoma (CTCL) - new purified formulation

Information

I/ONTAK
New formulation
Citius Pharma
Citius Pharma

Development and Regulatory status

None
None
Phase III Clinical Trials
Yes
Yes

Category

Recombinant fusion protein combining interleukin-2 (IL-2) receptor binding domain with diphtheria toxin fragments. Administered by iv infusion over 60 minutes on on 5 consecutive days during every cycle of 21 days [2] I/ONTAK is a reformulation of ONTAK which was marketed in the US from 1999 to 2014 when it was withdrawn from the market. Manufacturing improvements resulted in a new formulation, which maintains the same amino acid sequence but features improved purity and bioactivity [3]
CTCL affects ~ 0.74 in 10,000 people in the EU, equivalent to around 28,000 people [4]
Persistent or recurrent cutaneous T-cell lymphoma (CTCL) - new purified formulation
Intravenous infusion