Eye­ing stan­dard of care sta­tus in 3rd-line TNBC, Gilead nails down full OK for Trodelvy with a slight­ly broad­er la­bel

Even as the FDA gets tough on drugs that miss their mark af­ter ac­cel­er­at­ed ap­provals, the agency is still quick to re­ward the ones that hit it.

Gilead is tout­ing one such case in Trodelvy, which clamped down a full OK just un­der one year af­ter it was ini­tial­ly cleared for use in triple-neg­a­tive breast can­cer. It’s al­so a broad­er ap­proval — ex­pand­ing the pa­tient pop­u­la­tion to in­clude those with un­re­sectable lo­cal­ly ad­vanced TNBC, not just metasta­t­ic cas­es. Pa­tients must have re­ceived two or more pri­or sys­temic ther­a­pies, at least one of them for metasta­t­ic dis­ease.

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