Innate Pharma received Breakthrough Therapy Designation from the FDA for lacutamab, its anti-KIR3DL2 antibody, for treating relapsed or refractory Sézary Syndrome (SS) in adults. This designation is based on promising Phase 1 and 2 trial results showing efficacy and a favorable safety profile in patients previously treated with mogamulizumab. This rare and aggressive form of cutaneous T-cell lymphoma often leaves patients with a poor quality of life, highlighting the need for new treatment options.
This FDA designation significantly accelerates lacutamab’s development pathway, potentially bringing a much-needed therapy to patients sooner. The positive clinical data, particularly in patients who have exhausted other treatment options including mogamulizumab, suggests lacutamab could become a crucial part of SS treatment. This also represents a critical step forward in addressing the unmet needs of this patient population who often face limited effective therapies.
Lacutamab’s Breakthrough Therapy Designation builds on prior Fast Track designation from the FDA in 2019 and PRIME designation from the European Medicines Agency in 2020. Innate Pharma is currently working with regulatory agencies on a confirmatory Phase 3 trial and actively seeking a partner for further development.
This breakthrough designation underscores lacutamab’s potential to reshape the SS treatment landscape. The accelerated development and review process could lead to faster market entry, offering hope to patients suffering from this aggressive disease and potentially establishing lacutamab as a key therapy in this area. Further development and the planned Phase 3 trial will be pivotal in confirming these early positive results and solidifying lacutamab’s role in addressing the unmet medical needs in SS.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
