Everest Medicines , a biopharmaceutical company focused on developing and commercializing transformative pharmaceutical products to address critical unmet needs in Asia Pacific markets, announced that the Health Sciences Authority (HSA) of Singapore has approved Trodelvy (sacituzumab govitecan or SG) for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) who have received two or more prior systemic therapies, at least one of them for metastatic disease. This marks the first drug approval of Trodelvy received by Everest. The Company expects a series of approvals for Trodelvy in its license territories in the coming year.
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“As part of our larger business strategy to build a robust commercial presence in Asia Pacific markets, we are well-positioned to accelerate quickly during this next phase of growth with an established commercial team, bridging the gap between patients with unmet medical needs and first-in-class biopharmaceutical innovation,” said Kerry Blanchard, MD, PhD, Chief Executive Officer of Everest Medicines. “As a next step we will be working collaboratively with all stakeholders to bring Trodelvy to women in Singapore living with metastatic TNBC.”
“TNBC accounts for 15-20% of all breast cancer cases in Singapore, and breast cancer is the country’s leading cause of cancer death in women. This aggressive and difficult-to-treat form of the disease has historically had very limited treatment options, with overall survival remaining unchanged among patients for nearly two decades,” said Yang Shi, Chief Medical Officer for Oncology at Everest Medicines. This regulatory milestone brings Trodelvy one step closer to Singaporean patients with metastatic TNBC.”
In addition to Singapore, Everest is closely coordinating with regulatory bodies in Greater China and South Korea 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 May 2021, the China National Medical Products Administration accepted its Biologics License Application for Trodelvy with priority review.
- 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 its NDA for Trodelvy. Trodelvy was previously granted Pediatric and Rare Severe Disease Priority Review Designation in Taiwan.
TNBC is the most aggressive type of breast cancer and accounts for approximately 15% of all breast cancers. 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 do not have estrogen and progesterone receptors and have limited human epidermal growth factor receptor 2 (HER2). Due to the nature of TNBC, effective treatment options are extremely limited compared with other breast cancer types. TNBC has a higher chance of recurrence and metastases than other breast cancer types. The average time to metastatic recurrence for TNBC is approximately 2.6 years compared with 5 years for other breast cancers, and the relative five-year survival rate is much lower. Among women with metastatic TNBC, the five-year survival rate is 12%, compared with 28% for those with other types of metastatic breast cancer.