Gilead's Trodelvy gets full FDA approval for triple-negative breast cancer

The FDA announced Wednesday that it granted regular approval to Gilead Sciences' Trodelvy (sacituzumab govitecan) for patients with unresectable, locally advanced or metastatic triple-negative breast cancer (TNBC) treated with two or more prior systemic therapies, including at least one for metastatic disease. It was Immunomedics that initially received accelerated approval for Trodelvy a year ago for third-line TNBC, with Gilead eventually adding the Trop-2-directed antibody-drug conjugate to its own oncology portfolio when it bought the company for $21 billion last October (for more, see ViewPoints: Gilead learns its ADCs).

The initial clearance was based on a single-arm Phase II trial demonstrating Trodelvy was associated with an objective response rate of 33.3% and a duration of response of 7.7 months. This latest decision was backed by data from the confirmatory Phase III ASCENT study, which had been stopped early because of "compelling" evidence of efficacy.

The FDA said that in addition to Trodelvy achieving the primary endpoint with median progression-free survival of 4.8 months, compared to 1.7 months for chemotherapy, ASCENT results also showed it prolonged overall survival to a median 11.8 months, versus 6.9 months for chemotherapy. Further, Trodelvy significantly improved overall response and clinical benefit rates as well. The agency said the application, which had been granted priority review and a breakthrough designation, was reviewed using the Real-Time Oncology Review pilot programme.

Jefferies & Co. analysts previously suggested that Trodelvy could become a go-to treatment for TNBC, with projected sales possibly reaching $480 million in 2022, and perhaps even surpassing that if studies in other tumour types are successful. The drug, which generated sales of $49 million in the fourth quarter of 2020, is currently under accelerated review in the EU as a treatment for TNBC.

For related analysis, see ESMO ViewPoints: Immunomedics makes its case for TNBC expansion.

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