The European Medicines Agency (EMA) Committee for Orphan Medicinal Products has granted orphan drug designation to LSTA1, Lisata Therapeutics’ lead product candidate for the treatment of pancreatic cancer.
Currently, LSTA1 is the subject of multiple ongoing and planned clinical studies being conducted globally in a variety of solid tumor types, including pancreatic cancer, in combination with a variety of anti-cancer regimens.
“Pancreatic cancer has one of the highest mortality rates of all cancers and affects hundreds of thousands of patients worldwide each year. Although progress has been made in understanding and treating pancreatic cancer, there remains significant unmet medical need,” stated Kristen K. Buck, M.D., Executive Vice President of R&D and Chief Medical Officer of Lisata.
“To date, LSTA1 has demonstrated favorable safety, tolerability, and activity to enhance delivery of standard-of-care chemotherapy for patients with metastatic pancreatic cancer. Obtaining orphan drug designation from the EMA reinforces our belief that LSTA1 offers major improvement in treating patients with this terrible disease.
“We are excited by the promise of LSTA1 for the treatment of pancreatic cancer and other solid tumors and are committed to advancing our development programs with the goal of providing a benefit to patients.”
Orphan drug designation in the European Union (EU) is granted by the European Commission based on a positive opinion adopted by the EMA Committee for Orphan Medicinal Products.
The EMA’s orphan designation is given to drugs and biologics in the EU for conditions defined as rare diseases, which affect no greater than 5 in 10,000 people in the EU.
Companies that meet the EMA’s orphan designation criteria are eligible for incentives that may include protocol assistance from the EMA, potential fee reductions, and EU marketing exclusivity of the particular indication for 10 years after approval.