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Gilead’s Trodelvy approved for triple-negative breast cancer in Europe

European patients with metastatic triple-negative breast cancer can now receive the antibody-drug conjugate as second-line monotherapy


A month after receiving a positive opinion from the European Medicine Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP), Gilead Science’s Trodelvy (sacituzumab govitecan) has been approved in Europe.

The therapy is now indicated as monotherapy for the treatment of adults with unresectable (cannot be removed by surgery) or metastatic triple-negative breast cancer (TNBC) who have received two or more prior systemic therapies, with at least one of them used for advanced disease.

Trodelvy is a first-in-class antibody and topoisomerase inhibitor conjugate that is directed to the Trop-2 receptor, a protein that is overexpressed in several tumours including metastatic TNBC and is associated with poor survival and relapse.

The approval is based on results from the phase 3 ASCENT trial of more than 500 patients randomised on either Trodelvy or chemotherapy. Gilead’s therapy improved both progression-free and overall survival.

TNBC is the most aggressive type of breast cancer and is diagnosed more frequently in younger and premenopausal women, as well as in Black and Hispanic women. Effective treatment options are extremely limited in TNBC compared with other breast cancer types and the chance of recurrence and metastases is higher.

“The metastatic stage of TNBC is particularly challenging to treat and until now we have urgently needed new treatment options for people in Europe living with this condition,” said Dr Véronique Diéras from the department of medical oncology at the Centre Eugène Marquis in Rennes, France. “Today’s approval including second-line metastatic TNBC is significant for the community as it’s another important step forward in helping women with this disease live longer.”

Trodelvy is approved in second-line metastatic TNBC in multiple countries worldwide, including Australia, Canada, Great Britain and Switzerland as well as the United States where it is also approved for metastatic urothelial cancer.

Not all triple negative breast cancers are the same – in 2011, scientists analysed the genetics of tumour samples from 587 patients with triple negative disease and grouped them into six groups, each with different genetic features.

This makes it much harder to create new treatments for the disease. While patients whose tumours express PD-L1 can receive immunotherapies like Merck/MSD’s Keytruda (pembrolizumab), advanced TNBC remains a very difficult cancer to treat. Roche had to withdraw its US accelerated approval for its immuno-oncology drug Tecentriq (atezolizumab) in combination with chemotherapy earlier this year when a post-marketing study failed to show benefit.

Article by
Hugh Gosling

24th November 2021

From: Regulatory



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