Everest Medicines, a biopharmaceutical company focused on developing and commercializing transformative pharmaceutical products to address critical unmet needs in Asia Pacific markets, announced 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.
“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.”
“There is a significant unmet need among metastatic triple-negative breast cancer patients in China who are waiting eagerly for a better treatment option to extend their lives,” said Kevin Guo, Chief Commercial Officer at Everest Medicines. “With the Trodelvy approval in China, we will rapidly expand our sales team to launch this novel product in the fourth quarter this year and bring it to as many hospitals and patients in China as possible.”
In addition to mainland China and Singapore where Trodelvy has been approved, Everest is closely coordinating with regulatory bodies in South Korea, Taiwan and Hong Kong to review its applications for Trodelvy 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 December 2021, the Ministry of Food and Drug Safety (MFDS) of South Korea accepted a New Drug Application (NDA) for Trodelvy. Trodelvy was previously granted Fast Track Designation and Orphan Drug Designation in South Korea.
- In December 2021, the Taiwan Food and Drug Administration accepted submission of NDA for Trodelvy. Trodelvy was previously granted Pediatric and Rare Severe Disease Priority Review Designation in Taiwan.
- In January 2022, the Health Sciences Authority of Singapore approved the Company’s NDA for Trodelvy for the treatment of second-line and later-line metastatic TNBC.
- In March 2022, an NDA was submitted to the Department of Health, the Hong Kong Special Administrative Region, China, for Trodelvy for the treatment of second-line metastatic TNBC.