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# Lisata Orphan Status for Osteosarcoma Drug
- URL: https://www.fdaweb.com/lisata-orphan-status-for-osteosarcoma-drug/
- Published: 2024-04-10T12:00:00.000Z
- Updated: 2026-09-14T14:27:59.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5156748

FDA has granted Lisata Therapeutics an orphan drug designation for LSTA1 and its use in treating osteosarcoma, a rare cancer that can develop in children, adolescents and young adults. The investigational drug is designed to activate a “novel uptake pathway that allows co-administered or tethered (i.e., covalently bound) anti-cancer drugs to penetrate solid tumors more effectively,” the company says. “LSTA1 actuates this active transport system in a tumor-specific manner, resulting in systemically co-administered anti-cancer drugs more efficiently penetrating and accumulating in the tumor.”

The company says the therapy has the potential to modify the tumor microenvironment in a way that could make it more susceptible to immunotherapies. Lisata and its partners have collected non-clinical data that demonstrate “enhanced delivery of a range of existing and emerging anti-cancer therapies, including chemotherapeutics, immunotherapies, and RNA-based therapeutics,” the company says, adding that LSTA1 has shown “favorable safety, tolerability, and activity in clinical trials to enhance delivery of SoC \[standard of care\] chemotherapy for pancreatic cancer.”

Previously, FDA granted the company orphan drug status for the therapy and its use in treating pancreatic cancer.