Gilead Sciences, Inc. (NASDAQ: GILD) shares began the last session before a long week on the right foot. The company 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 authorization of Trodelvy® (sacituzumab govitecan-hziy) as a 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 Trodelvy 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 maximize patient outcomes.
“Metastatic TNBC 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.
GILD shares started the session up $3.10, or 2.4%, to $133.60.
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