The European Commission (EC) has approved the Menarini Group’s Orserdu (elacestrant) as a monotherapy for certain patients with advanced or metastatic breast cancer, Menarini and its subsidiary Stemline Therapeutics announced.
The EU regulator’s decision specifically applies to postmenopausal women and men with oestrogen receptor (ER) positive, HER2-negative, locally advanced or metastatic breast cancer with an activating ESR1 mutation.
Eligible patients will also have experienced disease progression following at least one line of endocrine therapy, including a CDK 4/6 inhibitor.
Each year in Europe, more than 550,000 people are diagnosed with breast cancer, 70% of whom have ER-positive disease.
ESR1 mutations are present in up to 40% of ER+, HER2-advanced or metastatic breast cancers and are a known driver of resistance to standard endocrine therapy, making these tumours more difficult to treat.
The EC’s approval makes Orserdu the first treatment specifically for patients with ER+, HER2-advanced or metastatic breast cancer tumours that harbour ESR1 mutations and was supported by results from the late-stage EMERALD trial, which demonstrated statistically significant progression-free survival (PFS) with Orserdu versus standard care.
In a subgroup of patients whose tumours had ESR1 mutations, Orserdu achieved a median PFS of 3.8 months compared to 1.9 months in the standard care cohort and also reduced the risk of progression or death by 45%.
Additionally, a post hoc subgroup analysis of the EMERALD PFS results showed that the duration of prior CDK4/6i treatment was positively associated with longer PFS on Orserdu but not with standard care.
For patients with ESR1 mutations who were treated with CDK4/6i for 12 months or over prior to randomisation on EMERALD, Orserdu achieved a median PFS of 8.6 months versus 1.9 months on SOC, with a 59% reduction in the risk of progression or death.
Elcin Barker Ergun, Menarini’s chief executive officer, 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.”