Gilead Sciences, Inc. GILD obtained approval FDA approved for the label expansion of breast cancer drug Trodelvy (sacituzumab govitecan-hziy), a first-in-class Trop-2-directed antibody-drug conjugate (ADC).
The regulatory body approved the drug for the first-line treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC).
Consequently, 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.
Trodelvy 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).
The latest FDA approval comes shortly after the European Commission expanded Trodelvy’s label for the same indication.
Gilead’s shares have gained 2% year to date compared with the industry's growth of 0.9%.
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More on GILD’s Trodelvy Label Expansion
The FDA’s approval was based on highly statistically significant and clinically meaningful progression-free survival (PFS) results from the late-stage ASCENT-03 and ASCENT-04/KEYNOTE-D19 studies. Data from these studies showed that Trodelvy-based regimens significantly lowered the risk of disease progression or death.
In ASCENT-03, Trodelvy monotherapy reduced this risk by 38% compared with chemotherapy in patients with PD-L1–ineligible disease, while in ASCENT-04, Trodelvy combined with Keytruda cut the risk by 35% versus Keytruda plus chemotherapy in patients with PD-L1+ disease.
Trodelvy-based regimens also demonstrated substantially more durable responses across both trials. Median duration of response reached 12.2 months with Trodelvy versus 7.2 months with chemotherapy in ASCENT-03, and 16.5 months with Trodelvy plus Keytruda versus 9.2 months with Keytruda plus chemotherapy in ASCENT-04.
The National Comprehensive Cancer Network (NCCN) 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, based on findings from the ASCENT-03 and ASCENT-04 studies.
Trodelvy also holds Category 1 recommendations for second-line treatment of mTNBC and for patients with previously treated HR-positive/HER2-negative mBC.
Trodelvy continues to gain market share in the second-line setting. Approval in additional indications will further boost sales.
It is being studied in several ongoing phase III clinical studies across multiple tumor types characterized by high Trop-2 expression. Studies are underway in lung and gynecologic cancers, where earlier proof-of-concept trials have already demonstrated encouraging clinical activity.
However, earlier this month, Merck and Gilead Sciences announced the discontinuation of the phase III KEYNOTE-D46/EVOKE-03 study evaluating Trodelvy in combination with Keytruda as a first-line treatment for patients with metastatic non-small cell lung cancer (NSCLC) whose tumors express high levels of PD-L1 (TPS ≥50%).
The open-label phase III study sponsored by Merck evaluated Trodelvy in combination with Keytruda versus Keytruda alone in this NSCLC patient population. The decision follows a recommendation from the external Data Monitoring Committee after reviewing the pre-specified final PFS analysis and an interim overall survival (OS) analysis.
While the combination demonstrated a numerical improvement in PFS compared with Keytruda alone, the result did not achieve statistical significance. The committee concluded that the likelihood of demonstrating a statistically significant OS benefit at the final analysis was low.
GILD’s Efforts to Diversify Portfolio
Gilead’s robust HIV franchise continues to maintain momentum, driven by the solid performance of Biktarvy and Descovy, and incremental contributions from Yeztugo.
Simultaneously, GILD is looking to strengthen its oncology franchise.
Gilead’s recent aggressive dealmaking strategy, including the acquisition of Arcellx and Tubulis, highlights the company’s commitment to diversifying beyond its core HIV franchise into higher-growth oncology and immunology markets.
GILD’s Zacks Rank and Stocks to Consider
Gilead currently has a Zacks Rank #3 (Hold). Some better-ranked stocks in the biotech sector are Liquidia Corporation LQDA and Immunocore IMCR, both currently sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Over the past 60 days, estimates for Liquidia’s 2026 earnings per share have risen from $1.50 to $2.97, while those for 2027 have increased from $2.91 to $4.81. LQDA’s shares have surged 119% year to date.
Liquidia’s earnings beat estimates in three of the trailing four quarters and missed in one, with the average surprise being 54.40%.
Over the past 60 days, 2026 loss per share estimates for Immunocore have narrowed from 97 cents to 16 cents, while 2027 estimates have improved from a loss of 39 cents to earnings of 11 cents per share.
Immunocore’s earnings beat estimates in three of the trailing four quarters and missed in one, with the average surprise being 46.66%.
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This article originally published on Zacks Investment Research (zacks.com).