The Medicines and Healthcare products Regulatory Agency has approved imlunestrant tosylate, branded as Inluriyo, for adults with a specific type of breast cancer that is locally advanced or metastatic and has not responded, or has progressed, after at least one line of hormonal therapy.
The treatment is indicated for cancers that are oestrogen receptor‑positive and HER2‑negative, and can only be used in patients with certain ESR1 gene mutations.
Oestrogen receptors are proteins that activate when the hormone binds to them, which in some cases can drive cancer cell growth.Imlunestrant binds to these receptors, breaking them down and preventing them from functioning.
By blocking and destroying oestrogen receptors, the medicine can slow the growth and spread of breast cancer and help kill cancer cells.Inluriyo is taken once daily as an oral tablet.
Julian Beach, Interim Executive Director of Healthcare Quality and Access at the MHRA, said: “Patient safety is our top priority.”
He added: “The approval of imlunestrant tosylate (Inluriyo) provides a new treatment for adults with recurrent or metastatic breast cancer after prior hormone treatment hasn’t been effective. As with all licensed medicines, we will continue to monitor its safety closely as it becomes more widely used.”
Common side effects include increased liver enzymes, tiredness, joint, bone and muscle pain, diarrhoea, raised triglycerides, nausea and back pain.
A full list of side effects will be available in the Patient Information Leaflet and the Summary of Product Characteristics, which will be published on the MHRA website within seven days of approval.
