Europe approves ‘Trodelvy’ (Gilead) against second-line metastatic triple negative breast cancer

MADRID, 23 Nov. (EUROPA PRESS) –

Gilead Sciences announced on Tuesday that the European Commission (EC) has granted marketing authorization to sacituzumab govitecan (under the trade name ‘Trodelvy’) as a monotherapy indicated for the treatment of adult patients with unresectable triple negative breast cancer (CMTN) or metastatic who have received two or more previous systemic treatments, at least one of them for advanced disease.

“The metastatic stage of CMTN is especially difficult to treat and we urgently needed new treatment options for people with this disease in Europe. Today’s approval, which includes second-line metastatic CMTN, is significant for the entire medical community already which is an important step in helping women with this disease to live longer, “said Dr. Véronique Diéras, lead medical oncologist of the Breast Cancer Group of the Department of Medical Oncology at the Eugène Marquis Center in Rennes (France).

CMTN is the most aggressive type of breast cancer, accounting for approximately 15 percent of all breast cancers. It is most often diagnosed in young and premenopausal women and is more common in black and Hispanic women.

The 5-year survival rate for this subtype of breast cancer is 12 percent, compared with 28 percent for other types of breast cancer, and these poor results are often accompanied by a significant decline in the quality of breast cancer. life, especially in relapsed / refractory disease.

“At Gilead, we are trying to push our limits to offer transformative science and novel treatment options that address urgent medical needs. We understand how difficult it is to treat metastatic CMTN and we are proud that ‘Trodelvy’ can now offer a second-line treatment option. with the potential to extend the lives of people living with this aggressive disease, “said Gilead Sciences Medical Director Merdad Parsey.

The European Commission’s decision is supported by the results of the phase 3 ‘ASCENT’ study, which shows that the molecule reduced the risk of death by 49 percent and improved the median overall survival to 11.8 months versus to 6.9 months with chemotherapy chosen by the doctor.

These data also showed a statistically significant and clinically significant 57 percent reduction in risk of death or disease worsening and an improvement in median progression-free survival (PFS) up to 4.8 months from 1, 7 months observed with physician-chosen chemotherapy alone among all randomized patients, which included those with and without brain metastases.

The most common grade 3 or higher adverse reactions were neutropenia (49.5 percent), leukopenia (12.0 percent), diarrhea (10.7 percent), anemia (10.1 percent), febrile neutropenia ( 6.6 percent), fatigue (5.2 percent), hypophosphatemia (5.2 percent), nausea (4.1 percent), and vomiting (3.0 percent).

In addition to this authorization for the European market, the treatment is approved in Australia, Canada, the United Kingdom, Switzerland and the United States for the treatment of metastatic CMTN. A regulatory review is also underway in Singapore and China with applications submitted by Everest Medicines. Furthermore, this drug has recently been included in the updated ESMO Clinical Practice Guidelines as a preferred treatment option for metastatic CMTN after taxanes.

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