Everest Medicines has submitted a new drug application (NDA) in Hong Kong for sacituzumab govitecan (SG) to treat metastatic triple-negative breast cancer (mTNBC).
The company filed the NDA with the Department of Health in the Hong Kong Special Administrative Region.
The SG drug is a first-in-class Trop-2 directed antibody-drug conjugate and is designed with hydrolysable linker attached to a topoisomerase I inhibitor payload SN-38.
It is intended to treat unresectable locally advanced or mTNBC in adult patients who have received two or more systemic therapies before, including at least one for metastatic disease.
SG is already approved in more than 35 countries for the same indication.
Additionally, the company is closely coordinating with regulatory bodies in mainland China, Taiwan, and South Korea to review the applications for the drug.
In the US, SG is approved under the accelerated approval pathway to treat locally advanced or metastatic urothelial cancer (UC) in adult patients who received a platinum-containing chemotherapy previously and the either programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor.
Everest Medicines Oncology chief medical officer Yang Shi said: “This submission reinforces the ongoing momentum in the development of SG throughout Asia, bringing this medicine one step closer to patients in yet another important region in Asia, and adding to the growing number of regulatory applications under active review.
“As women diagnosed with mTNBC have historically had minimal treatment options available to them and breast cancer has become the most common cause of death in women in Hong Kong over the past few decades, this application is especially timely.
“We look forward to moving closer to our goal of making SG an accessible treatment option for women throughout Greater China.”
The company announced the topline results for its Phase IIb EVER-132-001 study of SG in November last year. The study included 80 subjects in China.
Last month, Trodelvy received approval in Singapore for second-line mTNBC.