Will the Label Expansion of Trodelvy Strengthen GILD's Oncology Portfolio?
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Gilead Sciences, Inc . GILD recently won FDA approval for the label expansion of breast cancer drug Trodelvy (sacituzumab govitecan-hziy) for the first-line treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC). Trodelvy, a first-in-class Trop-2-directed antibody-drug conjugate (ADC), is already approved in several countries for second-line or later metastatic TNBC and in more than 50 countries for certain patients with pre-treated HR+/HER2- metastatic breast cancer (mBC). With the latest FDA approval, Trodelvy is now approved in first-line mTNBC, either as a single agent for patients who are not candidates for PD-(L)1 inhibitor-based therapy or in combination with Merck 's MRK Keytruda (pembrolizumab) or Keytruda Qlex (subcutaneous injection of Keytruda) for patients whose tumors express PD-L1 (CPS ≥10) as determined by an FDA-authorized test. The latest FDA approval came shortly after the European Commission expanded Trodelvy's label for the same indication. The approval broadens Trodelvy's addressable market by moving the therapy into the first-line mTNBC setting, where treatment options have historically been limited. The approval is significant particularly because many mTNBC patients do not progress to later lines of therapy, making access to effective first-line treatments increasingly important. According...
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