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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