04 January 2022 | Tuesday | News
Image Source : mediscape
Everest Medicines Limited (HKEX 1952.HK, "Everest", or the "Company"), a biopharmaceutical company focused on developing and commercializing transformative pharmaceutical products in Asia, announced today that Taiwan Food and Drug Administration (TFDA) has accepted the submission of a New Drug Application (NDA) for sacituzumab govitecan (SG) in 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. The treatment was granted Pediatric and Rare Severe Disease Priority Review Designation by the Taiwan FDA in July 2021.
"This regulatory milestone is another important step in the ongoing global development of sacituzumab govitecan as a novel treatment option for patients with mTNBC. We will be working with the regulatory authorities in Taiwan to help bring the treatment to patients with metastatic TNBC who have limited alternative options." said Yang Shi, Chief Medical Officer for Oncology at Everest Medicines.
Under the trade name Trodelvy®, the U.S. FDA previously granted accelerated approval to SG in April 2020 and then expanded its indication with full approval in April 2021 for adult patients with unresectable locally advanced or mTNBC who have received two or more prior systemic therapies, at least one of them for metastatic disease. In May 2021, Everest announced that the China National Medical Products Administration accepted its 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.
In November 2021, Everest announced topline results for its Phase 2b EVER-132-001 study of SG, which met its primary endpoint with a 38.8% overall response rate (ORR). This study included 80 people in China, and the results were consistent with those from the global Phase 3 ASCENT study, thus showing similar efficacy in the Chinese population.