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# Citrus Plans I/ONTAK Lymphoma Drug BLA
- URL: https://www.fdaweb.com/citrus-plans-i-ontak-lymphoma-drug-bla/
- Published: 2022-07-12T12:00:00.000Z
- Updated: 2026-09-14T17:51:35.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5152248

Citrus Pharmaceuticals says that as a result of a pre-BLA meeting with FDA, it plans to submit a BLA later this year for I/ONTAK (denileukin diftitox) to treat patients with persistent or recurrent cutaneous T-cell lymphoma. The company [says](https://citiuspharma.com/investors/news-media/news/release-details/2022/Citius-Pharmaceuticals-Inc.-Holds-Pre-BLA-Meeting-with-the-FDA-for-IONTAK-denileukin-diftitox-for-the-Treatment-of-Cutaneous-T-Cell-Lymphoma/default.aspx?ref=fdaweb.com) I/ONTAK is a purified and more bioactive formulation of ONTAK that was approved previously by FDA and marketed from 1999 to 2014\. It was voluntarily withdrawn, the company says.

“Manufacturing improvements resulted in a new formulation, which maintains the same amino acid sequence but features improved purity and bioactivity,” Citrus says. FDA has granted I/ONTAK orphan drug designation for treating peripheral T-cell lymphoma and cutaneous T-cell lymphoma.