Gilead Sciences Korea said on Tuesday that its metastatic triple-negative breast cancer (TNBC) drug, Trodelvy (ingredient: sacituzumab govitecan-hziy), obtained approval from the Ministry of Food and Drug Safety (MFDS).

The drug is indicated for the treatment of adult patients with unresectable locally advanced or metastatic TNBC who have received two or more systemic therapies, at least one of which was for metastatic disease.

Trodelvy is the first TROP-2-targeted antibody-drug conjugate (ADC), consisting of a monoclonal antibody that binds to the cell surface antigen TROP-2, which is highly expressed in more than 90 percent of breast and bladder cancers. It also includes SN-38, which has potent cell-killing activity.

By targeting TROP-2, the drug selectively attacks cancer cells, providing a potent effect on TROP-2-expressing cells and the tumor microenvironment.

TNBC is a type of breast cancer in which both hormone receptor (HR) and human epithelial growth factor receptor type 2 (HER2) are not expressed. However, it has a low overall survival rate among breast cancers, as it is difficult to treat effectively with targeted therapies due to its cancer characteristics.

The Korean regulator’s decision was granted based on the phase 3 ASCENT study of 529 patients with unresectable, locally advanced, or metastatic TNBC who met the trial conditions.

In the study, the median progression-free survival (mPFS) was evaluated as the primary endpoint. The mPFS in the Trodelvy group was 4.8 months compared to 1.7 months in the control group using the treatment of physician choice (TPC). Additionally, it showed a 57 percent reduction in the risk of disease progression or death.

Meanwhile, Trodelvy almost doubled the control group’s 6.9 median overall survival (mOS) demonstrating an mOS of 11.8 months and a 49 percent reduction in the risk of death.

Regarding, serious adverse events, 27 percent of patients receiving the drug showed adverse events. Among them, 7 percent exhibited neutropenia, 4 percent diarrhea, 3 percent pneumonia, and 5 percent had adverse events leading to treatment discontinuation.

"Trodelvy is Gilead's first anticancer drug in Korea, and we believe it can change the treatment paradigm for TNBC, which has a high unmet medical need,” said Dr. Lee Joo-yeon, Medical Director at Gilead Sciences Korea. "We will continue to introduce innovative treatments in the anticancer space to improve access to care for cancer patients locally."