On May 20, 2021 Everest Medicines (HKEX 1952.HK), a biopharmaceutical company focused on developing and commercializing transformative pharmaceutical products in Greater China and other parts of Asia, reported that sacituzumab govitecan-hziy (SG) was granted Priority Review by the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) (Press release, Everest Medicines, MAY 20, 2021, View Source [SID1234580409]).
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This marks another progress following the Company’s announcement published on 17 May 2021 that the NMPA accepted its Biologics License Application (BLA) for 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.
"We are very pleased by the NMPA’s decision to grant Priority Review for SG, reinforcing its potential to serve as a novel and important treatment option to people in China suffering the devastating effects of metastatic triple-negative breast cancer," said Yang Shi, Chief Medical Officer for Oncology at Everest Medicines. "We look forward to working closely with local regulatory bodies to bring this innovative treatment to patients in China as quickly as possible."
"This exciting milestone is one of many recent global clinical and regulatory advances that further enables us to accelerate the pace at which we work to bring this first-of-its-kind therapy to patients in need," said Kerry Blanchard, MD, PhD, CEO of Everest Medicines.
In October 2020, SG was included in the updated 2020 China Guidelines for the Standardized Diagnosis and Treatment of Advanced Breast Cancer, compiled by the Breast Cancer Expert Committee of the National Cancer Control Center, the Breast Cancer Professional Committee of the Chinese Anti-Cancer Association, and the Cancer Drug Clinical Research Professional Committee of the Chinese Anti-Cancer Association.
Under the trade name Trodelvy, the U.S. Food and Drug Administration (FDA) previously granted accelerated approval to SG in April 2020 and full approval to SG in April 2021 for adult patients with unresectable locally advanced or metastatic triple-negative breast cancer who have received two or more prior systemic therapies, at least one of them for metastatic disease.
About Triple-Negative Breast Cancer
Triple-negative breast cancer (TNBC) is a highly aggressive disease and accounts for approximately 15% of all breast cancer types worldwide. The median age of breast cancer diagnoses tends to be younger in Asian than western countries, and the percentage of the TNBC molecular subtype has been increasing in the past 10 years. TNBC cells lack sufficient estrogen, progesterone or HER2 receptor expression to benefit from the use of hormonal or HER2-directed therapy. Overall survival among patients with this form of breast cancer has not changed in the past 20 years, which highlights the need for advances in therapeutic options for these patients.
About Sacituzumab Govitecan-hziy
Sacituzumab govitecan-hziy (SG) is a first-in-class, antibody and topoisomerase inhibitor conjugate directed at TROP-2, a protein frequently expressed in multiple types of epithelial cancers. SG is approved in the United States under the trade name Trodelvy.
Under a licensing agreement with Gilead Sciences, Inc., Everest Medicines has exclusive rights to develop, register, and commercialize SG for all cancer indications in Greater China, South Korea, and certain Southeast Asian countries.
The Ministry of Food and Drug Safety (MFDS) in South Korea has granted Fast Track Designation and Orphan Drug Designation (ODD) to SG for the treatment of metastatic TNBC. In addition, Everest announced in January 2021 that it submitted a New Drug Application (NDA) to the Health Sciences Authority (HSA) of Singapore for SG for the treatment of patients with metastatic TNBC who have received at least two prior therapies for metastatic disease. That application is currently under review.