Families affected by lymphatic malformations know how limited treatment options can be and how urgently progress is needed. Protara Therapeutics recently announced encouraging news: the U.S. Food and Drug Administration (FDA) has granted both Breakthrough Therapy and Fast Track designations to TARA-002, an investigational therapy being studied for children with macrocystic and mixed cystic lymphatic malformations. The FDA also selected TARA-002 for its Chemistry, Manufacturing, and Controls (CMC) Development and Readiness Pilot Program, supporting efforts to accelerate development.
While these designations do not mean the therapy is approved, they signal that the FDA recognizes both the seriousness of lymphatic malformations and the need for new treatment options. For families, this represents an important step toward more focused research, faster collaboration with regulators, and continued momentum in advancing care for children living with lymphatic malformations.
