Everest Medicines announced that the Taiwan Food and Drug Administration has granted Pediatric and Rare Severe Disease Priority Review Designation for sacituzumab govitecan-hziy (SG), an investigational treatment for adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) who have received two or more prior systemic therapies, at least one of them for metastatic disease. Pediatric and Rare Severe Disease Priority Review Designation is granted by the Taiwan FDA to new drugs intended to address unmet medical need and treat a serious condition in which the prevalence of the disease is less than five per ten thousand. According to the Taiwan FDA, if a drug meets the criteria required to receive this designation, the drug shall be approved by expedited review process. Under the trade name Trodelvy, the U.S. FDA previously granted accelerated approval to SG in April 2020 and then expanded its previous indication with full approval in April 2021 for adult patients with unresectable locally advanced or metastatic TNBC who have received two or more prior systemic therapies, at least one of them for metastatic disease. In May 2021 Everest announced China National Medical Products Administration accepted Biologics License Application with priority review for SG for adult patients with unresectable locally advanced or metastatic TNBC who have received two or more prior systemic therapies, at least one of them for metastatic disease. That application is currently under review.