FDA Grants Orphan Drug Designation to PBI-200 for NTRK Fusion–Positive Solid Tumors
The FDA has granted an orphan drug designation to PBI-200 for the treatment of patients with NTRK fusion–positive solid tumors, including primary and metastatic brain tumors. PBI-200, which is an oral, highly potent and selective inhibitor of TRK kinase, was designed by Pyramid Biosciences to overcome a wide range of on-target resistance mutations that have been observed with first-generation TRK inhibitors. “Oncogenic NTRK gene fusions are found in a broad range of cancers. Orphan designation for drugs in development […]