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Gilead’s Trodelvy set for EU approval in breast cancer

The positive opinion from EMA’s CHMP means Trodelvy could be available as second-line treatment for unresectable or metastatic breast cancer before the end of the year

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Gilead’s Trodelvy (sacituzumab govitecan) has received a positive opinion from the European Medicine Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) as monotherapy for adult patients with unresectable or metastatic triple-negative breast cancer (TNBC).

To be eligible, patients must have already received two or more prior systemic therapies, at least one of them for advanced disease.

This is good news for European patients with TNBC, the most aggressive form of the disease, which is more frequently diagnosed in younger and premenopausal women as well as being more prevalent in black and hispanic women. The disease also has poor outcomes, with a five-year survival rate of 12% compared with 28% for other breast cancer types.

“Effective treatment options are extremely limited for patients with metastatic TNBC, especially once they progress. We are now one step closer to bringing this much needed treatment option to patients across Europe,” said Gilead CMO Merdad Parsey.

The FDA approved Trodelvy for the same indication in April and the drug is also available in the UK, Australia, Switzerland and Canada, with reviews currently underway in Singapore and China.

Gilead expects a final European Commission decision later this year.

Trodelvy is a first-in-class antibody-drug conjugate that targets Trop-2, a protein on the surface of cells that is overexpressed in TNBC.

The CHMP decision was based on results from the phase 3 ASCENT study, which reported that patients receiving Trodelvy saw a 57% reduction in risk of the disease worsening or death as well as an improved progression-free survival – the study’s primary endpoint – of 4.8 months compared to 1.7 months for patient receiving chemotherapy.

The treatment reduced the risk of death by 49% and improved median overall survival to 11.8 months over 6.9 months for physician’s choice of chemotherapy.

Gilead’s development programme for Trodelvy includes potential use in other TNBC and metastatic urothelial cancer, for hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) metastatic breast cancer and metastatic non-small cell lung cancer, as well as multiple solid tumours.

Article by
Hugh Gosling

18th October 2021

From: Regulatory

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