Trodelvy (sacituzumab govitecan)
Q2 2026 sales rose 26% to $457 million. First-line triple-negative breast cancer approval came in June 2026.
The numbers
What it is
Trodelvy is an antibody-drug conjugate for metastatic breast cancer. On June 24, 2026 the FDA approved it as a first-line treatment for unresectable or metastatic triple-negative breast cancer, as monotherapy for patients who are not candidates for PD-1 or PD-L1 inhibitors and with Keytruda for tumors with PD-L1 CPS of 10 or higher. Gilead discontinued the Phase 3 EVOKE-03 lung cancer study in Q2 2026.
Why it matters to the stock. The approval moves Trodelvy from later lines of treatment into first-line triple-negative breast cancer, the main oncology growth lever outside cell therapy. The pivotal trials showed a 38 percent (ASCENT-03) and 35 percent (ASCENT-04) lower risk of progression or death.
News
Gilead Q2 2026 revenue rises 10% to $7.8 billion; GAAP loss on acquired R&D charges
Gilead reported second-quarter 2026 total revenue of $7,803 million, up 10% from a year earlier, led by HIV medicines, Trodelvy and Livdelzi.
EU regulator backs Trodelvy plus Keytruda for first-line PD-L1-positive breast cancer
The EMA's CHMP recommended Trodelvy combined with Keytruda for adults with unresectable or metastatic triple-negative breast cancer who have not had prior systemic therapy for metastatic disease and whose tumors are PD-L1 positive (CPS 10 or higher).
FDA approves Trodelvy for first-line metastatic triple-negative breast cancer
The FDA approved Trodelvy as a first-line treatment for metastatic triple-negative breast cancer.
Merck and Gilead stop Phase 3 KEYNOTE-D46/EVOKE-03 lung cancer study
Merck and Gilead said an independent Data Monitoring Committee recommended stopping the Phase 3 trial of Trodelvy plus Keytruda in previously untreated PD-L1-high non-small cell lung cancer.
EMA's CHMP backs Trodelvy monotherapy for first-line triple-negative breast cancer in Europe
The EMA's CHMP adopted a positive opinion recommending Trodelvy as a monotherapy for adults with unresectable or metastatic triple-negative breast cancer who are not candidates for PD-1 or PD-L1 inhibitors.
Gilead Q1 2026 beats: product sales ex-Veklury up 8%, product guidance raised, EPS guidance cut to a loss
Gilead's first-quarter revenue rose 4% to $6.96 billion, and product sales excluding Veklury grew 8% to $6.8 billion.
Gilead to buy Germany's Tubulis for $3.15 billion upfront, up to $5 billion total
Gilead agreed to buy Munich-based Tubulis, a developer of antibody-drug conjugates, for $3.15 billion in cash at closing plus up to $1.85 billion in milestones.