FDA approve Gilead’s breast cancer treatment after Phase III trial
pharmafile | April 8, 2021 | News story | | FDA, Gilead, Trodelvy, pharma, pharma news
The FDA has approved Gilead’s Trodelvy therapy for the treatment of metastatic triple-negative breast cancer (TNBC).
The decision comes after the treatment was shown to improve progression-free survival (PFS) and overall survival (OS) in a Phase III trial.
The Phase III ASCENT study randomised 500 patients with relapsed/refractory TNBC to either receive Troveldy or a chemotherapy chosen by the patients’ treating physicians.
Trodelvy demonstrated a statistically significant 57% reduction in the risk of disease worsening, or death (PFS), extending median PFS to 4.8 months from 1.7 months with chemotherapy. Trodelvy also extended median OS to 11.8 months vs. 6.9 months, representing a 49% reduction in the risk of death.
The treatment will now be available for patients in the US with locally advanced or metastatic TNBC who have received two or more prior systemic therapies, at least one of them for metastatic disease.
Trodelvy is a first-in-class antibody directed to the Trop-2 receptor, a protein frequently expressed in multiple types of epithelial tumours, including metastatic TNBC, where high expression is associated with poor survival and relapse.
The treatment is also being developed as an investigational treatment for metastatic urothelial cancer, another form of metastatic breast cancer, and metastatic non-small cell lung cancer.
TNBC is an aggressive type of breast cancer, accounting for approximately 15% of all breast cancers. The disease is diagnosed more frequently in younger and premenopausal women and is more prevalent in African American and Hispanic women.
Dr Aditya Bardia, Director of the Breast Cancer Research Program at the Mass General Cancer Center, and global principal investigator of the ASCENT study, said: “Women with TNBC have historically had very few effective treatment options and faced a poor prognosis.
“Today’s FDA approval reflects the statistically significant survival benefit seen in the landmark ASCENT study and positions Trodelvy as a potential standard of care for pre-treated TNBC.”
Dr Merdad Parsey PhD, Chief Medical Officer at Gilead Sciences, added: “Today’s approval is the culmination of a multi-year development program and validates the clinical benefit of this important treatment in metastatic TNBC.
“Building upon this milestone, we are committed to advancing Trodelvy with worldwide regulatory authorities so that, pending their decision, Trodelvy may become available to many more people around the world who are facing this difficult-to-treat cancer.”
Jack Goddard
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