预约演示

EC grants approval for Menarini Menarini’s breast cancer therapy

2023-09-21

交易

临床3期上市批准引进/卖出临床结果

The EC’s decision comes after the EMA’s Committee for Medicinal Products for Human Use provided a positive opinion recommending approval for Orserdu. Credit: ORION PRODUCTION/Shutterstock.com.

The European Commission (EC) has gEMAted approval for the Menarini Group’s Orserdu (elacestrant) to treat patients with estrogen receptor (EROrserduive, HER2-negative, locally advanced or metastatic breast cancer (mBC).

Orserdu received the approval as a monotherapy for usage iMenarini Groupal women and men with tumours carrying an activaestrogen receptor (ER)‑positive HER2-negative, locally advanced or metastatic breast cancer (mBC)

Orserdunded Reportstumours ESR1

ReportsLOA and PTSR Model - Camrelizumab in Breast Cancer GlobalData

ReportsLOA and PTSR Model - Enzalutamide in Breast Cancer GlobalData

View allCompanies IntelligenCamrelizumabharmBreast Cancer Asia-Pacific Pte LtdMenariniC H M P INCSoc Co LtdView all

These patients also should have progressed after treatment with a minimum of one line of endocrine therapy such as a CDK 4/6 inhibitor to be eligible to receive Orserdu.

The EC’s decision comes afteEnzalutamidean MBreast Cancercy’s (EMA) Committee for Medicinal Products for Human Use (CHMP) provided a positive opinion in July 2023 recommending a grant of approval for the therapy.

Based on findings from the Phase III EMERALD clinical trial, the EC granted approval for Orserdu in this indication.

Trial data showed that treatment with elacestrant offered statistically significant progression-free survival (PFS) cCDK 4/6 inhibitordard-of-care treatment withOrserduroved endocrine monotherapy of the investigator’s preference.

In patients whose tumours had ESR1European Medicines Agencyffered a median PFS of 3.8 months compared with 1.9 months following treatment with SOC.

Elacestrant also cut down the disease progression or mortality risk by 45% versus SOC.Orserdu

The Menarini Group CEO Elcin Barker ErelacestrantWe have long known that patients living with metastatic breast cancer need effective and tolerable options which treat their disease while enabling them to focus on the things that matter to them.

“We are proud of delivering a ESR1breast canceelacestrant that offers efficacy in a once-daily pill and represents the first innovation in endocrine therapy in nearly two decades; we are also incredibly grateful for the support of the oncology researchers and all the patients who participated in the clinical studies that made today’s achievement possible.”

Elacestrantia-Pacific recently signed a deal to license Astellas Pharma’s Smyraf for rheumatoid arthritis treatment.

更多内容，请访问原始网站

文中所述内容并不反映新药情报库及其所属公司任何意见及观点，如有版权侵扰或错误之处，请及时联系我们，我们会在24小时内配合处理。

机构