U.S. FDA Orphan Drug Designation Granted to LSTA1 for the Treatment of Osteosarcoma
“We are thrilled to have received another favorable regulatory designation from the FDA. This underscores the significant unmet medical need and demand for better treatments for patients diagnosed with osteosarcoma,” stated Kristen K. Buck, M.D., Executive Vice President of R&D and Chief Medical Officer of Lisata. “Osteosarcoma, while rare, is a type of bone cancer that is often associated with high morbidity, early metastasis, rapid progression, and poor prognosis. Receiving an ODD from the FDA is an important milestone as we plan for future clinical expansion of LSTA1, and we believe it reflects the broad clinical utility of LSTA1 for the treatment of a wide array of solid tumors.”
Share:
More News
“Fast Track designation in lung cancer represents an important milestone for TRE-515 and further validates our strategy of combining dCK inhibition with targeted cancer therapies,” said Dr. Ken Schultz, Trethera Chairman and CEO. “KRAS G12C inhibitors have transformed the NSCLC treatment landscape, but resistance and incomplete responses remain major challenges.
“AvenCell has built a differentiated cell therapy platform that brings together CRISPR-engineered allogeneic CAR-T technology with a unique switchable CAR approach designed to provide greater control over CAR-T activity,” said Todd Davis, CEO of Ligand. “We believe the combination of these technologies, together with the encouraging clinical data generated to
“Advanced gastric cancer is characterized by substantial biological and clinical heterogeneity. Previous studies have shown that the magnitude of benefit from PD-1 inhibitor therapy is closely associated with PD-L1 expression, and that there remains room to further improve outcomes, particularly in patients with low PD-L1 expression. How to broaden the
“The evERA results represent an important step forward for people with ER-positive advanced breast cancer and underscore the potential for giredestrant to help address the challenge of disease progression in this setting,” said Levi Garraway, MD, PhD, Roche’s Chief Medical Officer and Head of Global Product Development. “Together with the