Innate Pharma : FDA Grants Breakthrough Therapy Designation To Lacutamab For R/R Sezary Syndrome

(RTTNews) - Innate Pharma SA (IPHA) announced Monday that the U.S. Food and Drug Administration has granted Breakthrough Therapy Designation to lacutamab, an anti-KIR3DL2 cytotoxicity-inducing antibody, for the treatment of adult patients with relapsed or refractory Sezary Syndrome after at least 2 prior systemic therapies including mogamulizumab.

The FDA's Breakthrough Therapy Designation aims to expedite the development and regulatory review process for drugs that target serious conditions. This designation is granted to treatments that have demonstrated promising early clinical results, suggesting a significant improvement on key clinical endpoints compared to existing therapies.

Lacutamab previously received a Fast Track designation by the FDA in 2019 for the treatment of adult patients with relapsed or refractory Sezary syndrome who have received at least two prior systemic therapies as well as a PRIME designation by European Medicines Agency in 2020.

IPHA closed Friday's trading at $1.94 up $0.0300 or 1.57%.

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