Gilead Sciences, Inc. GILD announced that the FDA has granted full approval to Trodelvy (sacituzumab govitecan-hziy) for adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (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 and topoisomerase inhibitor conjugate directed to the Trop-2 receptor, a protein frequently expressed in multiple types of epithelial tumors.
The regulatory body granted accelerated approval to Trodelvy in April 2020 based on objective response rate and duration of response results in a phase 1/2 study.
The full approval expands this indication to include treatment of adult patients with unresectable locally advanced or metastatic TNBC who have received two or more prior systemic therapies, at least one of them for metastatic disease.
The approval is supported by impressive data from the late-stage ASCENT study, wherein Trodelvy demonstrated a statistically significant and clinically meaningful 57% reduction in the risk of disease worsening or death. Trodelvy also extended median overall survival (OS) to 11.8 months versus 6.9 months, representing a 49% reduction in the risk of death.
Among all patients evaluable for safety in the ASCENT study, Trodelvy had a safety profile consistent with the previously approved FDA label.
The drug is also being evaluated as an investigational treatment for metastatic urothelial cancer, hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER 2-) metastatic breast cancer and metastatic non-small cell lung cancer.
The European Medicines Agency has also validated a Marketing Authorization Application for Trodelvy for metastatic TNBC in the European Union.
The acquisition of Immunomedics, Inc. in October 2020 added Trodelvy to Gilead’s oncology portfolio, which comprises cell therapies like Yescarta and Tecartus. The massive decline in sales of its HCV franchise has led the company to focus on the HIV franchise and the oncology portfolio.
Gilead’s stock has gained 12.6% in the year so far against the industry’s decline of 6.7%.
While the breast cancer market has significant potential, given the widespread prevalence, competition is stiff in this space from Roche’s RHHBY strong portfolio of drugs like Perjeta, Kadcyla and Tecentriq, and AstraZeneca (AZN) and Merck’s MRK Lynparza (olaparib).
Gilead currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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