GILD Expands Trodelvy Approval
Gilead's Trodelvy receives FDA approval for unresectable locally advanced or metastatic triple-negative breast cancer
S. ’s (NASDAQ: GILD ) Trodelvy (sacituzumab govitecan-hziy) for unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC), significantly expanding the drug’s role in first-line treatment. Under the expanded label, Trodelvy can now be used as a standalone treatment in first-line mTNBC patients who are not eligible for PD-(L)1 inhibitor-based therapy. ’s (NYSE: MRK ) Keytruda (pembrolizumab) or Keytruda Qlex for patients whose tumors express PD-L1 with a combined positive score of at least 10.
Read Also: Gilead And Merck End Trodelvy-Keytruda Lung Cancer Trial Phase 3 Studies Show Significant Reduction In Disease Progression Risk The approval was supported by data from the Phase 3 ASCENT-03 and ASCENT-04/KEYNOTE-D19 studies. In ASCENT-03, Trodelvy monotherapy reduced the risk of disease progression or death by 38% compared with chemotherapy in patients who were not eligible for PD-L1-directed treatment. Meanwhile, in the ASCENT-04 trial, the combination of Trodelvy and Keytruda lowered the risk of disease progression or death by 35% compared with Keytruda plus chemotherapy in patients with PD-L1-positive disease.
Trodelvy Demonstrates More Durable Responses Across both studies, Trodelvy-based regimens produced longer-lasting responses than chemotherapy. 2 months for chemotherapy. 2 months for those treated with Keytruda and chemotherapy. NCCN Endorses Trodelvy Across PD-L1 Status Following the positive ASCENT-03 and ASCENT-04 findings, the National Comprehensive Cancer Network recommends Trodelvy, with or without Keytruda, as a category 1 preferred first-line treatment option for mTNBC regardless of PD-L1 status.
Trodelvy also carries category 1 recommendations in second-line mTNBC and in previously treated HR-positive/HER2-negative metastatic breast cancer. Gilead said more than 75,000 breast cancer patients across over 60 countries have received Trodelvy during the past six years. The company added that the therapy remains the only Trop-2-directed antibody-drug conjugate to demonstrate overall survival benefits in both later-line metastatic TNBC and pre-treated HR-positive/HER2-negative metastatic breast cancer. 80 at the time of publication on Thursday, according to Pro data.
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