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EC grants marketing approval for Trodelvy, a breast cancer treatment

European Commission (EC) grants Gilead Sciences marketing approval for Trodelby® (Sashitsuzumabugobitecan), indicated for the treatment of adult patients with unresectable or metastatic triple-negative breast cancer (TNBC) who have received two or more previous systemic therapies (at least one of which is a progressive disease) As a single agent therapy.

TNBC is the most aggressive type of breast cancer, accounting for about 15% of all breast cancers. It is more often diagnosed in young, premenopausal females and more common in blacks and Hispanic females. The 5-year survival rate for this subtype of breast cancer is 12%, compared to 28% for other breast cancer types, and these poor prognosis significantly reduce quality of life, especially in relapsed / refractory diseases. Often associated with. ..

In addition to this approval, Trodelvy has been approved for metastatic TNBC in Australia, Canada, the United Kingdom, Switzerland, and the United States. Regulatory reviews are also underway in Singapore and China, with applications submitted by Everest Medicines. Trodelvy was recently included in the updated ESMO clinical practice guidelines as the preferred treatment option for metastatic TNBC after taxane administration.

Dr. Veronique Dieras, Senior Medical Oncologist Head, Breast Cancer Group, Breast Cancer Group, Center Eugene Marquis, Rennes, France, said: In Europe living in this state. Today’s approval, including secondary metastatic TNBC, is important to the community as it is another important step in supporting the longevity of women with this disease. “

Dr. Murdad Percy, MD, Chief Medical Officer of Gilead Sciences, said: Understanding how difficult it is to treat metastatic TNBC, we are proud to offer Trodelvy a second-line treatment option that may extend the lifespan of people with this invasive disease. “

EC grants marketing approval for Trodelvy, a breast cancer treatment

Source link EC grants marketing approval for Trodelvy, a breast cancer treatment

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