FOSTER CITY, Calif., July 24, 2026
Gilead Sciences announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending the approval of Trodelvy® (sacituzumab govitecan-hziy) in combination with Keytruda® (pembrolizumab) for the first-line treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) whose tumors are PD-L1-positive (CPS ≥10) and who have not received prior systemic therapy for metastatic disease. The recommendation marks a significant regulatory milestone and now awaits a final decision from the European Commission, expected later in 2026. If approved, the combination would establish Trodelvy as a backbone first-line therapy across PD-L1-defined patient populations in the European Union, expanding treatment options for one of the most aggressive forms of breast cancer.
Phase 3 Trial Demonstrates Significant Progression-Free Survival Benefit
The CHMP recommendation is supported by results from the Phase 3 ASCENT-04/KEYNOTE-D19 trial, which demonstrated a highly statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared with the current standard-of-care regimen of chemotherapy plus Keytruda. Patients treated with the Trodelvy and Keytruda combination experienced a 35% reduction in the risk of disease progression or death, highlighting the combination’s potential to improve first-line outcomes in PD-L1-positive metastatic TNBC. The study also incorporated a patient-centered crossover design, allowing participants receiving chemotherapy to switch to Trodelvy after disease progression. Clinical investigators emphasized that first-line therapy may represent the only treatment opportunity for many patients with metastatic TNBC due to the disease’s rapid progression and poor overall prognosis.
Potential to Expand Trodelvy’s Role Across Breast Cancer Treatment
According to Gilead, the positive opinion follows the recent European approval of Trodelvy monotherapy for patients who are not candidates for PD-1 or PD-L1 inhibitor therapy, strengthening the company’s growing leadership in HER2-negative metastatic breast cancer. If the European Commission grants marketing authorization, Trodelvy plus Keytruda would become an additional first-line option for PD-L1-positive metastatic TNBC, complementing the existing monotherapy indication. The therapy is already approved in the United States, where the FDA has authorized Trodelvy both as a standalone treatment and in combination with Keytruda for eligible first-line metastatic TNBC patients. Company executives noted that this recommendation further reinforces Trodelvy’s position as the only Trop-2-directed antibody-drug conjugate (ADC) with multiple positive Phase 3 studies demonstrating clinical benefit across different metastatic breast cancer settings.
Advertisement
Trodelvy Continues to Strengthen Gilead’s Oncology Pipeline
Triple-negative breast cancer (TNBC) accounts for approximately 15% of all breast cancer cases and remains one of the most difficult cancers to treat because it lacks estrogen, progesterone, and HER2 receptors, limiting targeted treatment options. Trodelvy, a first-in-class Trop-2-directed antibody-drug conjugate, is designed to selectively deliver the topoisomerase I inhibitor SN-38 directly to cancer cells while also producing a bystander effect within the tumor microenvironment. More than 75,000 breast cancer patients have received the therapy worldwide since its initial launch in 2020, and it currently holds approvals across multiple metastatic breast cancer indications. Beyond breast cancer, Gilead Sciences continues to evaluate Trodelvy in several ongoing Phase 3 clinical trials involving lung and gynecologic cancers, supporting the company’s strategy of expanding the therapy across additional Trop-2-expressing tumors and strengthening its global oncology portfolio with innovative antibody-drug conjugate technologies.
Source: Gilead Sciences press release
