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# Innate Pharma Fast Track for Sezary Syndrome
- URL: https://www.fdaweb.com/innate-pharma-fast-track-for-sezary-syndrome/
- Published: 2019-01-29T12:00:00.000Z
- Updated: 2026-09-15T00:58:31.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5143242

FDA has granted Innate Pharma a fast track designation for IPH4102 and its use in treating adult patients with relapsed or refractory Sezary syndrome who have received at least two prior systemic therapies. The company describes the therapy as a first-in-class anti-KIR3DL2 antibody, developed for treating T-cell lymphoma.

Sezary syndrome is the most aggressive form of cutaneous T-cell lymphoma, Innate Pharma says. “We intend to initiate a global multi-cohort Phase II study (TELLOMAK) in the first half of 2019 to confirm the clinical activity of IPH4102 in Sezary syndrome and evaluate the potential in other subtypes of T-cell lymphomas, including Mycosis fungoides (MF) and peripheral T-cell lymphoma (PTCL).”

Fast track was granted based on preliminary results from a Phase I dose-escalation and expansion study of IPH4102 in advanced cutaneous T-cell lymphoma. Data from the Sezary syndrome subgroup (35 patients) revealed “strong clinical activity, demonstrated by an overall response rate (ORR) of 42.9%, median duration of response (DoR) of 13.8 months and median progression-free survival (PFS) of 11.7 months,” the company says.