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Everest Medicines Announces First Drug Approval of Trodelvy® in Singapore for Second-Line Metastatic Triple-Negative Breast Cancer

Singapore Health Sciences Authority (HSA) approval marks the first in a series of expected approvals of Trodelvy in Asia.

Everest Medicines, a biopharmaceutical company focused on developing and commercialising transformative pharmaceutical products to address critical unmet needs in Asia Pacific ;markets, announced in February 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.

TNBC is the most aggressive type of breast cancer and accounts for approximately 15 per cent 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 per cent, compared with 28 per cent for those with other types of metastatic breast cancer.

Trodelvy is a first-in-class antibody and topoisomerase inhibitor conjugate directed to the TROP-2 receptor, a protein overexpressed in multiple types of epithelial tumours, including metastatic TNBC and metastatic urothelial cancer (UC), where high expression is associated with poor survival and relapse. Trodelvy is approved for adults with second-line metastatic TNBC in the United States, the European Union, Australia, Canada, Great Britain and Switzerland, and approval is based on data submitted from the Phase ٣ ASCENT study. Review is also underway in Greater China and South Korea through Everest Medicines. Trodelvy is also approved under the accelerated approval pathway for use in metastatic UC in the United States and continues to be developed for potential use in other TNBC and metastatic UC populations. It is also being developed as an investigational treatment for hormone receptor-positive/human epidermal growth factor receptor ٢-negative (HR+/HER٢-) metastatic breast cancer and metastatic non-small cell lung cancer. Additional evaluation across multiple solid tumours is also underway.

Under a licensing agreement with Gilead Sciences, Inc., Everest Medicines has exclusive rights to develop, register, and commercialise 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 Standardised 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.

“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. [APBN]

Source: Everest Medicines