Everest Medicines, a biopharmaceutical company focused on developing and commercializing transformative pharmaceutical products to address critical unmet needs in Asia Pacific markets, announced today that China’s National Medical Products Administration (NMPA) has approved Trodelvy® (sacituzumab govitecan or SG) for the treatment of 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. This is the first drug that Everest has obtained New Drug Application (NDA) approval to launch in China. In May 2021, the NMPA accepted Everest’s NDA for Trodelvy with Priority Review designation.
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“We are extremely excited for Trodelvy’s NDA approval in China as Trodelvy is a first-in-class Trop-2-directed antibody-drug conjugate. This marks a significant milestone for Everest with our first drug approved in our home market, where we hope to continue to bring innovative therapies to people with urgent medical needs,” said Kerry Blanchard, MD, PhD, Chief Executive Officer of Everest Medicines. “We want to extend our gratitude to the NMPA and the Center for Drug Evaluation for the Priority Review and fast approval.”
“The NMPA approval of Trodelvy will provide an important and new treatment option for Chinese women with metastatic triple-negative breast cancer – a very aggressive and challenging to treat form of the disease. We would like to thank the investigators and patients who participated in the clinical trials for making this possible,” said Yang Shi, Chief Medical Officer for Oncology/Immunology at Everest Medicines. “We will continue to work with our partner, Gilead, to advance clinical research of Trodelvy across multiple tumor types as well as earlier lines of therapy.”
In November 2021, Everest announced topline results from its Phase 2b EVER-132-001 study of Trodelvy in 80 people, which met its primary endpoint with a 38.8% overall response rate (ORR). The results were consistent with those from the global Phase 3 ASCENT study, thus showing similar efficacy and safety in the Chinese population.
“Patients with triple-negative breast cancer are in urgent need of new and effective treatment options. I have witnessed the introduction of sacituzumab govitecan (Trodelvy) into China, and led the registrational clinical study in the nation,” said Professor Binghe Xu, academician of the Chinese Academy of Engineering and director of the National New Drug (Anti-Cancer) Clinical Research Centre who is the principal investigator of Trodelvy’s registrational study in China. “I am glad that sacituzumab govitecan has shown similar positive results in the domestic clinical study as those from the global trial. As a clinician, I hope that this new drug can reach patients as early as possible to save more lives.”