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Recently, Gilead Sciences announced that the US FDA has fully approved the targeted anti-cancer drug Trodelvy for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC).
The approval of Trodelvy was supported by data from a global, open-label Phase III ASCENT trial.
In terms of safety, in all ASCENT trial patients (n = 482), the trial results showed that the safety of Trodelvy was consistent with other indications approved by the FDA.
Trodelvy is a new and pioneering antibody-conjugated drug (ADC) targeting Trop-2.
In addition, Trodelvy’s application for a new indication is also under review by the US FDA for the treatment of neoadjuvant/adjuvant, metastatic diseases that have previously received platinum-containing chemotherapy and PD-1 inhibitors or PD-L1 inhibition.
In addition to the good news in the US market, the drug is also expected to make progress in the European Union.