Gilead gains EC approval for metastatic breast cancer drug Trodelvy
28 Jul 2023
Phase 3Drug ApprovalClinical ResultADC
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Source: Pharmaceutical Technology
Trodelvy is intended for use as a monotherapy to treat unresectable or metastatic HR)-positive, HER2-negative breast cancerHER2-negative breast cancer. Credit: CI Photos / Shutterstock.com.
Gilead Sciences has received approval from the European Commission (EC) for its antibody-drug conjugate Trodelvy (sacituzumab govitecan) for pre-treated hormone receptor (HR)-positive, HER2-negative metastatic breast cancer.
Trodelvy will be used as a single agent to treat unresectable or metastatic HR-positive, HER2-negative breast cancer patients who have received endocrine-based therapy, and a minimum of two additional systemic therapies in the advanced setting.
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The approval was granted after a positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP).
It is based on data from the TROPiCS-02 study, which showed a statistically significant and clinically meaningful overall survival benefit of 3.2 months against comparator single-agent chemotherapy.
The international multicentre, open-label, Phase III study assessed Trodelvy against physicians’ choice of chemotherapy in 543 cases of HR+/HER2- metastatic breast cancerHR+/HER2- metastatic breast cancer previously treated with endocrine therapy, a CDK4/6 inhibitorCDK4/6 inhibitor and two to four lines of chemotherapy for metastatic disease.
Gilead Oncology therapeutic area head and senior vice-president Bill Grossman stated: “Trodelvy could change the outlook for women with pre-treated HR+/HER2- metastatic breast cancerHR+/HER2- metastatic breast cancer by replacing the standard-of-care chemotherapy that has been their only option for decades.
“We look forward to working with European authorities to ensure access for these patients who need new treatment options.”
Trodelvy has received approval in more than 40 countries and is currently undergoing regulatory reviews worldwide.
It is approved to treat adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) who have undergone at least two prior systemic therapies, one of which was for metastatic disease.
Trodelvy is also being developed to treat other TNBC and HR+/HER2- metastatic and adjuvant breast cancerHR+/HER2- metastatic and adjuvant breast cancer patients.
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