European Commission Approves Trodelvy® as a First-Line Treatment for Metastatic Triple-Negative Breast Cancer Patients Not Candidates for PD-(l)1 Inhibitors

About this update from Gilead Sciences, Inc.

Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the European Commission (EC) has granted marketing authorization for Trodelvy® (sacituzumab govitecan-hziy) as monotherapy for the treatment of adult patients with unresectable or metastatic triple-negative breast cancer (TNBC) who have not received prior systemic therapy for metastatic disease and are not candidates for PD-1 or PD-L1 inhibitor therapy. Trodelvy is the first antibody-drug conjugate (ADC) to be approved in first-line metastatic TNBC in the European Union’s 27 member states, as well as Norway, Iceland and Liechtenstein. “This approval brings a profound sense of hope to a community that has long been waiting for progress,” said Dr. Javier Cortes, Head of the International Breast Cancer Center, Madrid and Barcelona, Spain. “For women diagnosed with metastatic TNBC, particularly those who are younger, every second counts, and having an effective treatment option that can delay the progression of their disease is invaluable. This is the kind of meaningful advance our community needs.” For many living with metastatic TNBC, the most aggressive form of breast cancer, first-line therapy may be their only line of treatment, creating an urgent need for effective treatment options to be used as early as possible. “This approval represents a significant step forward in how we treat people with first-line metastatic TNBC in Europe,” said Mika Kakefuda Derynck, MD, Senior Vice President, Clinical Development, Oncology at Gilead Sciences. “We have long recognized the challenges that patients and clinicians face with this aggressive cancer, and we believe this approval will provide a much-needed new option for people with metastatic TNBC.” The EC’s marketing authorization is based on data from the Phase 3 ASCENT-03 study which demonstrated a highly statistically significant and clinically meaningful progression-free survival for Trodelvy compared to standard of care chemotherapy as a first-line treatment. In ASCENT-03, Trodelvy demonstrated a 38% reduced risk of disease progression or death in patients who are not candidates for PD-1/PD-L1 inhibitors. The ASCENT-03 study utilized a patient-centered crossover design, which allowed patients in the chemotherapy arm to receive Trodelvy after their disease progressed. The EC’s approval, based on the strength of the PFS data, confirms the study's objectiv...

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