EC grant Trodelvy marketing authorisation for treatment of breast cancer

EC grant Trodelvy marketing authorisation for treatment of breast cancer

With the latest approval from the EC, patients in Europe suffering from metastatic triple-negative breast cancer can now receive Gilead Science’s Trodlevy as part of their treatment.

Gilead Sciences have announced the European Commission (EC) marketing authorisation of Trodelvy (sacituzumad govitecan), a first-in-class Trop-2-directed antibody-drug conjugate as a monotherapy for the treatment of adult patients with unresectable or metastatic triple-negative breast cancer (TNBC) who have received two or more prior systemic therapies, with at least one of them for advanced disease treatment.

TNBC is the most aggressive type of breast cancer and accounts for approximately 15% of all breast cancers. It is more frequently diagnosed in younger and premenopausal women and is more prevalent in Black and Hispanic women. The poor outcomes of this breast cancer are often coupled with a significant decrease in quality of life especially in relapsed and refractory disease. The five-year survival rate for this sub-type of breast cancer is 12%, a significantly lower figure than the 28% survival rate of other breast cancer types.

“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, Senior Medical Oncologist Head at the department of medical oncology, Centre Eugène Marquis, 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.”

The EC’s decision is supported by the results from the global, open-label, randomised Phase 3 ASCENT study, which met its primary and secondary endpoints of progression-free survival and overall survival. The study enrolled more than 500 patients across 230 study locations and evaluated the efficacy and safety of Trodelvy compared with a single-agent chemotherapy of the physician’s choice in patients with unresectable, locally advanced or metastatic TNBC who had received at least two prior treatments.

Merdad Parsey, Chief Medical Officer at Gilead Sciences said: “We understand how difficult metastatic TNBC is to treat and we’re proud that Trodelvy can now offer a second-line treatment option with the potential to bring longer life to people living with this aggressive disease.”

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