Triple-negative breast cancer (TNC) is a highly aggressive and currently difficult-to-treat disease, accounting for approximately 15% of all breast cancer types worldwide. In Asia, the median age of breast cancer diagnosis is trending younger compared to Western countries, and the proportion of the triple-negative breast cancer molecular subtype has been increasing annually over the past decade. TNC tumors lack sufficient estrogen, progesterone, and human epidermal growth factor receptor 2 (HER2). Due to the nature of TNC, effective treatment options are extremely limited compared to other types of breast cancer. TNC has a higher chance of recurrence and metastasis than other types of breast cancer. The average time to metastasis and recurrence for TNC is approximately 2.6 years, compared to 5 years for other breast cancers, resulting in a relatively lower 5-year survival rate. The 5-year survival rate is 12% for women with metastatic triple-negative breast cancer, compared to 28% for other types of metastatic breast cancer.
On April 7, 2021, Gilead Sciences announced that the U.S. Food and Drug Administration (FDA) has fully approved the marketing application of Trodelvy, an ADC drug targeting TROP-2, for the treatment of adult patients with non-resectable locally advanced or metastatic triple-negative breast cancer (TNBC)..
In December 2021, the Korean Ministry of Food and Drug Safety (MFDS) accepted Trodelvy's application for the listing of a new drug. Trodelvy has previously been granted rapid review process accreditation and orphan drug qualification in South Korea.
In December 2021, the Taiwan drug regulatory authority of China accepted Trodelvy's application for the listing of a new drug. Previously, Trodelvy had obtained the qualification for priority review of medicines for pediatric or a few serious diseases in Taiwan.
In January 2022, the Singapore Health Sciences Authority approved Trodelvy's application for the listing of a new drug for the second-line and later-stage treatment of metastatic triple-negative breast cancer.
In March 2022, Genting Xinyao submitted a new drug listing application for Trodelvy to the Department of Health of the Hong Kong Special Administrative Region of China for the second-line treatment of metastatic triple-negative breast cancer.
