Innate Pharma’s Lacutamab Receives FDA Breakthrough Therapy Designation

Innate Pharma SA has received Breakthrough Therapy Designation (BTD) from the U.S. FDA for lacutamab, a promising antibody therapy targeting relapsed or refractory Sézary syndrome (SS) in patients who have undergone at least two prior systemic treatments, including mogamulizumab. This designation is based on encouraging efficacy and safety results from both the Phase 1 trial and the Phase 2 TELLOMAK study, which highlighted lacutamab’s potential to improve patient outcomes in this aggressive form of cutaneous T-cell lymphoma.

Dr. Sonia Quaratino, Chief Medical Officer at Innate Pharma, emphasized the urgent need for new targeted therapies in Sézary syndrome, where patients often face poor quality of life and limited treatment options. With Breakthrough Therapy status, the company aims to accelerate the drug’s development in close collaboration with the FDA. Lacutamab has previously received Fast Track designation (2019) in the U.S. and PRIME designation (2020) from the EMA, reinforcing its potential as a transformative treatment for CTCL patients worldwide.