Novel metastatic breast cancer therapy gets TGA priority review
The antibody-drug conjugate is being fast-tracked to market because of its promise for patients with few other treatment options
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