Lisata Therapeutics, Inc. (LSTA) announced on Thursday that the U.S. Food and Drug Administration (FDA) has bestowed Rare Pediatric Disease Designation - known as RPDD - upon its candidate product, LSTA1. This product is being developed for the treatment of Osteosarcoma, a scarce form of cancer typically seen in bone-forming osteoblast cells and common amongst children, adolescents, and young adults.
Obtaining the RPDD is the first step towards securing a priority review voucher, thus accelerating the product’s journey towards potential market availability. Previously, LSTA1 was given orphan drug designations for pancreatic cancer in both the U.S. and Europe. Meanwhile, in the U.S., the drug has also been recognized for its potential in treating glioblastoma multiforme. In addition, the FDA has also granted LSTA1 a Fast Track designation for pancreatic cancer.
