Gilead Sciences announced that the U.S. Food and Drug Administration (FDA) has approved Trodelvy (sacituzumab govitecan-hziy) for the first-line treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC).
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 Keytruda (pembrolizumab) or Keytruda Qlex (pembrolizumab and berahyaluronidase alfa-mph) for patients whose tumors express PD-L1 (CPS ≥10).
The FDA approval was supported by highly statistically significant and clinically meaningful progression-free survival data from the Phase 3 ASCENT-03 and ASCENT-04/KEYNOTE-D19 trials.
The latest regulatory decision covers use of Trodelvy alongside both intravenously infused Keytruda and Keytruda Qlex, which is the subcutaneously injected version of the Merck drug.
The National Comprehensive Cancer Network (NCCN) now recommends Trodelvy with or without Keytruda as a category 1 preferred first-line treatment option for people with mTNBC across PD-L1 status in the NCCN Guidelines.
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