Gilead Sciences, Inc. today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion, recommending the marketing authorisation of sacituzumab govitecan-hziy as monotherapy for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) who have not received prior systemic therapy for metastatic disease and who are not candidates for PD-1 or PD-L1 inhibitor therapy.

The European Commission decision on the additional sacituzumab govitecan-hzi indication is anticipated later in 2026.

Metastatic TNBC is an aggressive form of breast cancer that is associated with low survival rates.

For many patients with metastatic TNBC, first-line therapy may be their only line of treatment, necessitating an urgency to act using the most effective treatment options first to maximise patient outcomes.

“Metastatic triple negative breast cancer remains one of the most challenging breast cancer subtypes to treat, particularly at the time of first diagnosis of advanced disease, when therapeutic options are limited for many patients,” said Dr. Javier Cortes, Head of the International Breast Cancer Center, Madrid and Barcelona, Spain.

“The CHMP’s positive opinion for sacituzumab govitecan represents an important step towards potential approval in this setting and reflects the clinically meaningful results observed in the ASCENT-03 study. Advancing effective treatment options earlier in the disease course is critical to improving outcomes for people living with metastatic TNBC.”

The CHMP’s recommendation is based on data from the Phase 3 ASCENT-03 study which demonstrated a highly statistically significant and clinically meaningful progression-free survival of sacituzumab govitecan-hzi compared to standard of care chemotherapy as a first-line treatment.

In ASCENT-03, sacituzumab govitecan-hzi demonstrated a 38% reduced risk of disease progression or death in patients who are not candidates for PD-1/PD-L1 inhibitors. 

Gilead has also submitted an application to the U.S. Food and Drug Administration for approval of sacituzumab govitecan-hzi in this indication based on the ASCENT-03 study.

“This positive CHMP opinion for sacituzumab govitecan-hzi represents a pivotal moment for people with metastatic TNBC across Europe, we look forward to hearing from the European Medicines Agency” said Mika Kakefuda Derynck Senior Vice President, Therapeutic Head, Oncology, Gilead Sciences.

“Building on the extensive clinical experience with sacituzumab govitecan-hzi in later lines of therapy, this recommendation has the potential to fundamentally change how we approach treating certain first-line metastatic TNBC patients, offering a much-needed option earlier in care when it can make the greatest difference. Each step forward means more options and more chances to change the story for people living this cancer.”

Gilead has also submitted supplemental filings to the European Medicines Agency and the U.S. Food and Drug Administration for sacituzumab govitecan-hzi in combination with pembrolizumab for patients with PD-L1 positive unresectable locally advanced or metastatic triple-negative breast cancer, based on data from the Phase 3 ASCENT-04 study.

These applications are currently under review. If approved, sacituzumab govitecan-hzi has the potential to be a backbone treatment across 1L mTNBC. 

Sacituzumab govitecan-hzi is currently approved as a second-line plus treatment for metastatic TNBC and for patients with pre-treated HR+/HER2-negative (IHC 0, IHC 1+ or IHC 2+/ISH-) metastatic breast cancer.

Healthcare professionals have substantial clinical experience with sacituzumab govitecan-hzi, with more than 75,000 breast cancer patients treated across 60+ countries since 2020.

It remains the only Trop-2-directed ADC to demonstrate meaningful overall survival benefits in both second-line or later metastatic TNBC and pre-treated HR+/HER2- metastatic breast cancer. It is also the only ADC with four positive Phase 3 trials in HER2-negative metastatic breast cancer (mBC) (IHC 0, IHC 1+ or IHC 2+/ISH-).

The use of sacituzumab govitecan-hzi plus pembrolizumab in patients with first-line PD-L1+ metastatic TNBC and sacituzumab govitecan-hzi as monotherapy in patients with first-line metastatic TNBC who are not candidates for PD-1/PD-L1 inhibitors are investigational, and the safety and efficacy of these uses have not been established.

Source: Gilead