According to a story from pm360online.com, the drug developer Innate Pharma SA recently announced that its experimental therapy IPH4102 has been granted Fast Track designation from the US Food and Drug Administration (FDA). This investigational drug, which is an innovative anti-KIR3DL2 antibody, has earned this designation as a therapy for patients with Sézary syndrome who have relapsed or refractory disease and have received treatment with two prior therapies.
About Sézary Syndrome
Sézary disease, also known as Sézary syndrome, is a type of T-cell cutaneous lymphoma. It is an incredibly rare disease that has yet to be studied extensively. The cause of Sézary disease still remains a mystery. The most prominent symptom of the disease is a bright red skin rash, or erythroderma. Other symptoms include swelling of the lymph nodes, spleen, and liver, abnormal thickening of the palms of the hands and the soles of the feet, and abnormal T-cells in the peripheral blood. Skin lesions that do not heal are another common symptom. Treatment for the disease is limited in effectiveness, but may include chemotherapy, photodynamic therapy, biologic therapy, and radiation. Men are more likely to get Sézary disease than women. To learn more about Sézary disease, click here.
About Fast Track Designation
Fast Track designation is a process intended to facilitate a faster development and approval cycle for drugs that have the potential to fulfill a currently unmet medical need or that display substantial advantages over currently available treatments for serious diseases. Fast Track confers several benefits, such as more communications and meetings with FDA officials, Rolling Review (which allows a company to submit its NDA or BLA as each section is completed instead of all at once), and potential eligibility for Priority Review and Accelerated Approval if other relevant criteria are satisfied.
The granting of this designation is due to favorable data from the Phase I study of IPH4102 in which the therapy produced a 42.9 percent overall response rate, median progression free survival rate of 11.7 months, a median response duration of 13.8 months. Quality of life measures in patients also correspondingly improved. These figures are a meaningful improvement for Sézary syndrome patients, whose disease relapses at a very high rate with current treatment approaches.