A first-in-class antibody-drug conjugate that almost doubles survival in metastatic triple-negative breast cancer is being evaluated for registration by the TGA under its priority review system.

The antibody-drug conjugate (ADC) sacituzumab govitecan (Trodelvy) received accelerated approval from the US Food and Drug Administration (FDA) in April last year and gained full approval in the US earlier this month.

It is indicated for use in adult patients with unresectable or locally advanced or metastatic triple-negative breast cancer who have received two or more prior systemic therapies, with at least one being for metastatic disease.

In the pivotal phase III ASCENT trial of 468 patients with relapsed or refractory metastatic triple-negative disease, median progression-free survival was 5.6 months with the conjugate therapy vs1.7 months among women given conventional chemotherapy.