Stemline Therapeutics receives FDA OK for Orserdu
Menarini has received the Food and Drug Administration’s nod for Orserdu for the treatment of postmenopausal women or adult men, with ER+, HER2-, ESR1-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy.
Stemline Therapeutics, a subsidiary of the Menarini Group will commercialize Orserdu in the United States.
"The FDA approval of Orserdu marks the first ever therapy for ER+, HER2- advanced or metastatic breast cancer patients with ESR1 mutations and we are very proud to offer a targeted therapy addressing this huge unmet need," said Elcin Barker Ergun, CEO of the Menarini Group. "We are grateful to the patients, investigators and administrators who participated in the clinical trials that led to this remarkable innovation."
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"Advanced or metastatic ER+, HER2- breast cancer pre-treated with endocrine-based therapy remains an area of unmet medical need. The last endocrine therapy approved was about 20 years ago, and effective endocrine options for this patient population are needed," said Aditya Bardia, director of Breast Cancer Research at Mass General Cancer Center, associate professor at the medicine department at Harvard Medical School and principal investigator for the EMERALD trial. "ESR1 mutations are a known driver of resistance to standard endocrine therapy, and so far, have been difficult to treat. The approval of elacestrant is welcomed as it offers a novel option for patients with ER+, HER2- metastatic breast cancer. This therapy targets the ESR1 mutations in metastatic breast cancer and provides patients with a convenient oral once-daily dose."
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"Each year 300,000 Americans are diagnosed with breast cancer and metastatic breast cancer causes the vast majority of deaths from the disease: more than 43,000 annually. We urgently need new and better treatment options to extend and improve the lives of people with metastatic breast cancer," said Sonya Negley, executive director of Metavivor. "We are thrilled to see the approval of Orserdu, a new oral endocrine therapy, for patients who have tumors that harbor ESR1 mutations, which are present in up to 40% of ER+, HER2- advanced or metastatic breast cancer. We advise patients to get tested for ESR1 mutations at progression in their metastatic treatment."