Key Summary
- MHRA approves Ogsiveo to help adults with progressive desmoid tumours
- Can slow disease, improve quality of life, and reduce need for surgery
- Can cause side effects including serious fertility and menopause concerns, so monitoring is essential
The Medicines and Healthcare products Regulatory Agency (MHRA) has approved Nirogacestat Hydrobromide (Ogsiveo) to help adults struggling with progressive desmoid tumours, which gets formed in connective tissue in the body, usually the arms, legs or abdomen.
They are non-cancerous tumours, but they damage nearby tissues and are difficult to remove.
Nirogacestat hydrobromide works towards curbing the proteins that help these tumours grow.
Studies have proven that the drug had increased the patients’ lifespan, stopped the condition from worsening, and avoided surgeries.
However, the drug comes with some side effects such as diarrhea, rashes, nausea, tiredness, hypophosphataemia (low blood levels of phosphates), headache, and stomatitis (inflammation of the lining of the mouth).
Premature menopause is a serious side effect of it, seen in more than one in ten people.
It is not suggested during pregnancy as it has the capacity to harm the unborn baby.
Nirogacestat hydrobromide’s impact on fertility remains unclear.
The level of damage it can cause to the female ovaries and male testicles is unknown.
“The approval of nirogacestat hydrobromide will benefit adults with desmoid tumours, improving health and quality of life,” commented Julian Beach, MHRA interim executive director, Healthcare Quality and Access.
He added that MHRA will closely monitor the safety and effectiveness of the drug.
