India, April 15 -- Immutep Limited (IMMP) announced that the U.S. FDA has granted Orphan Drug Designation for its immunotherapy candidate Eftilagimod alfa ("efti") for the treatment of soft tissue sarcoma, a rare cancer with significant unmet medical need.
Soft tissue sarcoma (STS) affects fewer than 200,000 people in the U.S. and is often difficult to treat. The FDA's ODD program provides incentives such as regulatory support, potential tax credits, fee exemptions, and seven years of market exclusivity upon approval.
The designation was supported by encouraging results from the Phase II EFTISARC-NEO trial, which evaluated efti in combination with radiotherapy and KEYTRUDA (pembrolizumab) in patients with resectable STS. In 38 evaluable p...