By Chris Wack
Innate Pharma shares were up 16% to $2.25 after the company said the Food and Drug Administration has granted Breakthrough Therapy Designation to lacutamab for the treatment of adult patients with relapsed or refractory Sezary Syndrome.
The company said the designation is granted based on Phase 1 study results as well as results from a Phase 2 where lacutamab demonstrated encouraging efficacy and a favorable safety profile in heavily pretreated, post-mogamulizumab patients with advanced Sezary syndrome.
Sezary Syndrome is a type of skin cancer that affects white blood cells called T lymphocytes.
A Breakthrough Therapy Designation by the FDA is intended to accelerate the development and regulatory review in the U.S. of drugs that are intended to treat a serious condition and that have shown encouraging early clinical results, which may demonstrate substantial improvement on a clinically significant endpoint over available medicines.
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.
Write to Chris Wack at chris.wack@wsj.com
(END) Dow Jones Newswires
February 18, 2025 09:53 ET (14:53 GMT)
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