The European Commission (EC) has granted approval for the Menarini Group’s Orserdu (elacestrant) to treat patients with estrogen receptor (ER)‑positive, HER2-negative, locally advanced or metastatic breast cancer (mBC).
Orserdu received the approval as a monotherapy for usage in postmenopausal women and men with tumours carrying an activating ESR1 mutation.
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 after the European Medicines Agency’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) compared with standard-of-care treatment with an approved endocrine monotherapy of the investigator’s preference.
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In patients whose tumours had ESR1 mutations, elacestrant offered 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.
The Menarini Group CEO Elcin Barker Ergun said: “We 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 new breast cancer treatment 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.”