The Medicines and Healthcare products Regulatory Agency (MHRA) has authorised Menarini Stemline UK’s Korserdu (elacestrant) to treat a subset of patients with advanced or metastatic breast cancer.
Korserdu has been specifically authorised for use as a monotherapy in 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 be experiencing disease progression following at least one line of endocrine therapy, including a CDK 4/6 inhibitor.
More than 55,000 new cases of breast cancer are diagnosed each year in the UK, of which 70% are ER-positive.
ESR1 mutations are acquired mutations that develop due to exposure to endocrine therapy and are present in up to 40% of ER-positive, HER2-negative advanced or metastatic breast cancers. They are a known driver of resistance to standard endocrine therapy, Menarini Stemline outlined, making tumours with these mutations more difficult to treat.
Korserdu works by attaching to the oestrogen receptors on hormone receptor-positive cancer cells, blocking oestrogen’s ability to attach to the cancer cells and help them grow.
Rick Coope, general manager at Menarini Stemline UK, said: “People living with metastatic breast cancer need effective and tolerable options, and we are proud of delivering a new breast cancer treatment which represents a major advance in endocrine therapy in a once daily pill.”
The marketing authorisation was supported by positive results from the late-stage EMERALD trial, which demonstrated a statistically significant improvement in progression-free survival with Korserdu versus standard of care, defined as an investigator’s choice of an approved endocrine monotherapy.
For the subset of patients whose tumours had ESR1 mutations, Korserdu was associated with a median progression-free survival of 3.8 months versus 1.9 months on the standard of care. The treatment was also shown to reduce the risk of progression or death by 45% compared to standard of care.
“As a practising oncologist, I am glad to now have a treatment option to offer my eligible patients that targets the mutations which make this form of breast cancer more difficult to treat,” said David Miles, professor of medical oncology at Mount Vernon Cancer Centre.