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Will the Label Expansion of Trodelvy Strengthen GILD's Oncology Portfolio?
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Key Takeaways
Gilead won FDA approval to expand Trodelvy into first-line treatment for metastatic TNBC.
Trodelvy generated $402 million in Q1 2026 sales, rising 37% on higher demand.
GILD aims to grow oncology and diversify beyond HIV as Trodelvy expands its market reach.
Gilead Sciences, Inc. (GILD - Free Report) 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 - Free Report) 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 to Gilead's management, the approval has the potential to establish Trodelvy as a new standard of care in first-line mTNBC, expanding its use beyond the second-line setting.
Trodelvy sales amounted to $402 million in the first quarter of 2026, up 37%, primarily driven by higher demand.
The recent label expansion is expected to strengthen Trodelvy's commercial opportunity and reinforce its position as a key growth driver within Gilead's oncology portfolio.
GILD is looking to strengthen its oncology franchise and diversify its revenue base, which is highly concentrated on HIV business.
Competition for GILD’s Oncology Business
Datroway (datopotamab deruxtecan), developed by AstraZeneca (AZN - Free Report) and Daiichi Sankyo, is also a TROP2-directed ADC.
It is approved in several countries worldwide for the treatment of adult patients with unresectable or metastatic HR-positive, HER2-negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who have received prior endocrine-based therapy and chemotherapy for unresectable or metastatic disease based on results from the TROPION-Breast01 trial.
In May 2026, AstraZeneca and Daiichi Sankyo announced that the Datroway has been approved in the United States for the treatment of adult patients with unresectable or mTNBC who are not candidates for PD-1/PD-L1 inhibitor therapy.
AstraZeneca and Daiichi Sankyo entered into a global collaboration agreement in March 2019 to jointly develop and commercialize Enhertu (trastuzumab deruxtecan), followed by a similar agreement for Datroway in July 2020. Daiichi Sankyo retains exclusive rights to both ADCs in Japan.
Merck is evaluating sacituzumab tirumotecan (sac-TMT), an investigational TROP2-directed ADC, in collaboration with Kelun-Biotech.
Merck is evaluating sac-TMT in 17 ongoing global phase III studies across multiple tumor types through the TroFuse clinical development program.
The program is evaluating sac-TMT across a diverse range of tumor types, including endometrial, bladder, breast, cervical, gastric, non-small cell lung and ovarian cancers, and it spans early-to-late-stage disease as both monotherapy and in combination with immunotherapies.
In May 2026, MRK announced that the phase III TroFuse-005 study evaluating sac-TMT met its primary endpoints of overall survival and progression-free survival in certain patients with advanced or recurrent endometrial cancer.
GILD’s Price Performance, Valuation and Estimates
Shares of GILD have gained 7% year to date, in line with the industry’s growth rate.
Image Source: Zacks Investment Research
Going by the price/earnings ratio, GILD’s shares currently trade at 28.73X forward earnings, higher than its mean of 11.98X and the large-cap pharma industry’s 19.11X.
Image Source: Zacks Investment Research
The consensus estimate for 2026 has deteriorated sharply over the past 30 days, shifting to a loss of 80 cents per share from earnings of $0.01 per share. The estimate for 2027 has edged up to $9.68 per share from $9.58 over the same period.
Image Source: Zacks Investment Research
While Gilead’s recent aggressive dealmaking strategy strengthens its long-term pipeline and growth potential, the sizable upfront payments and integration-related costs are pressuring near-term profitability.
View the Zacks #1 Rank List
Image: Shutterstock
Will the Label Expansion of Trodelvy Strengthen GILD's Oncology Portfolio?
Key Takeaways
Gilead Sciences, Inc. (GILD - Free Report) 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 - Free Report) 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 to Gilead's management, the approval has the potential to establish Trodelvy as a new standard of care in first-line mTNBC, expanding its use beyond the second-line setting.
Trodelvy sales amounted to $402 million in the first quarter of 2026, up 37%, primarily driven by higher demand.
The recent label expansion is expected to strengthen Trodelvy's commercial opportunity and reinforce its position as a key growth driver within Gilead's oncology portfolio.
GILD is looking to strengthen its oncology franchise and diversify its revenue base, which is highly concentrated on HIV business.
Competition for GILD’s Oncology Business
Datroway (datopotamab deruxtecan), developed by AstraZeneca (AZN - Free Report) and Daiichi Sankyo, is also a TROP2-directed ADC.
It is approved in several countries worldwide for the treatment of adult patients with unresectable or metastatic HR-positive, HER2-negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who have received prior endocrine-based therapy and chemotherapy for unresectable or metastatic disease based on results from the TROPION-Breast01 trial.
In May 2026, AstraZeneca and Daiichi Sankyo announced that the Datroway has been approved in the United States for the treatment of adult patients with unresectable or mTNBC who are not candidates for PD-1/PD-L1 inhibitor therapy.
AstraZeneca and Daiichi Sankyo entered into a global collaboration agreement in March 2019 to jointly develop and commercialize Enhertu (trastuzumab deruxtecan), followed by a similar agreement for Datroway in July 2020. Daiichi Sankyo retains exclusive rights to both ADCs in Japan.
Merck is evaluating sacituzumab tirumotecan (sac-TMT), an investigational TROP2-directed ADC, in collaboration with Kelun-Biotech.
Merck is evaluating sac-TMT in 17 ongoing global phase III studies across multiple tumor types through the TroFuse clinical development program.
The program is evaluating sac-TMT across a diverse range of tumor types, including endometrial, bladder, breast, cervical, gastric, non-small cell lung and ovarian cancers, and it spans early-to-late-stage disease as both monotherapy and in combination with immunotherapies.
In May 2026, MRK announced that the phase III TroFuse-005 study evaluating sac-TMT met its primary endpoints of overall survival and progression-free survival in certain patients with advanced or recurrent endometrial cancer.
GILD’s Price Performance, Valuation and Estimates
Shares of GILD have gained 7% year to date, in line with the industry’s growth rate.
Image Source: Zacks Investment Research
Going by the price/earnings ratio, GILD’s shares currently trade at 28.73X forward earnings, higher than its mean of 11.98X and the large-cap pharma industry’s 19.11X.
Image Source: Zacks Investment Research
The consensus estimate for 2026 has deteriorated sharply over the past 30 days, shifting to a loss of 80 cents per share from earnings of $0.01 per share. The estimate for 2027 has edged up to $9.68 per share from $9.58 over the same period.
Image Source: Zacks Investment Research
While Gilead’s recent aggressive dealmaking strategy strengthens its long-term pipeline and growth potential, the sizable upfront payments and integration-related costs are pressuring near-term profitability.
GILD currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.