Key Summary
- Sevabertinib approved to treat adults with HER2-positive lung cancer that has spread or cannot be removed by surgery.
- As with any medicine, the MHRA will keep the safety and effectiveness of sevabertinib under close review.
- Sevabertinib is indicated for patients whose cancer has progressed following prior treatment.
The Medicines and Healthcare products Regulatory Agency (MHRA) has approved sevabertinib (Hyrnuo) to treat lung cancers that cannot be removed by surgery.
It is meant for adults with advanced non-small cell lung cancer with HER2 mutations, that has spread to other parts of the body.
Sevabertinib is a protein kinase inhibitor that blocks abnormal HER2 protein which drives the growth of cancer cells.
By targeting this protein, the medicine can help to slow or stop the cancer from growing and, in some cases, shrink the tumour.
However, before starting treatment, patients should be tested for these mutations to ensure that the medicine is suitable for them.
During trials, Sevabertinib drew positive responses in 71 percent of previously treated patients with advanced HER2 mutations, and they lasted six months or longer.
Julian Beach, interim executive director of Healthcare Quality and Access at the MHRA, said: “The approval of sevabertinib (Hyrnuo) provides a new treatment for adults with HER2-positive lung cancer that has spread or cannot be removed by surgery.
“As with all licensed medicines, we will continue to monitor its safety closely as it becomes more widely used.”
The most common side effects of sevabertinib include diarrhoea, skin reactions, stomatitis (inflammation of the mouth) and paronychia (inflammation of skin surrounding toenails). Patients should speak to their healthcare professional if they experience any side effects.
Sevabertinib has been approved through Project Orbis, a global partnership between medicine regulatory bodies of different countries that reviews and approves promising cancer drugs.
Other than MHRA, it includes Therapeutics Goods Administration in Australia, Health Canada, the Health Sciences Authority in Singapore, Swissmedic, Agência Nacional de Vigilância Sanitária in Brazil and Israel’s Ministry of Health, coordinated by the US Food and Drug Administration.
