On July 29, 2021 Everest Medicines (HKEX 1952.HK), a biopharmaceutical company focused on developing and commercializing transformative pharmaceutical products that address critical unmet medical needs for patients in Greater China and other parts of Asia, reported that the Taiwan Food and Drug Administration (FDA) 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 (Press release, Everest Medicines, JUL 29, 2021, View Source [SID1234585418]).
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"Receiving Pediatric and Rare Severe Disease Priority Review Designation for SG in Taiwan is an important milestone in the ongoing development of this novel drug candidate, and follows the Orphan Drug Designation previously granted by the Ministry of Food and Drug Safety in South Korea," said Kerry Blanchard, MD, PhD, Chief Executive Officer of Everest Medicines. "We look forward to working closely with regulatory authorities to bring this treatment to patients in Taiwan as quickly as possible as we continue to pursue our goal of advancing potentially first-in-class medicines for patients in Greater China and other parts of Asia."
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.
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.
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.
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. 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.