Medicines Healthcare Products Regulatory Agency
The Medicines and Healthcare products Regulatory Agency (MHRA) has today (3 November 2023) authorised a new medicine called Krazati (adagrasib), a treatment for a type of non-small cell lung cancer (NSCLC) in adults that has a mutation and produces a rare protein called KRAS G12C.
It can be used to treat patients with this type of NSCLC when the disease is advanced or has spread to other parts of the body, and previous treatments have failed to stop the cancers growth.
The KRAS G12C protein causes the cancer cells to grow out of control. Krazati attaches to the protein and stops it from working, which may slow down or stop the growth of the cancer.
More than 43,000 people are diagnosed with lung cancer every year in the UK. Non-small cell lung cancer is the most common form of lung cancer, accounting for approximately 80-85% of cases.Of patients with NSCLC, it is estimated that 13-14% produce the KRAS G12C protein.
Krazati is available in 200mg tablet form, with the recommended dose of three tablets taken at the same times twice a day.
The most common side effects of the medicine are: low red blood cell counts which can cause tiredness and pale skin; low blood sodium levels which can causeheadache, tiredness, fits and coma; loss of appetite; feeling dizzy; nausea; diarrhoea; vomiting; blood test results indicating a sign of kidney problems; tiredness/weakness; swelling, especially of the ankles and feet, due to fluid retention; decreased level of white blood cells in the blood; abnormal blood test results indicating high levels of lipase and/or amylase in the blood stream; low blood potassium levels which can cause weakness, muscle cramps, tingling and heart rhythm disturbance; low levels of albumin, a blood protein.
As with any medicine, the MHRA will keep the safety and effectiveness of Krazati under close review. Anyone who suspects they are having a side effect from this medicine should talk to their doctor, pharmacist or nurse and report it directly to the Yellow Card scheme, either through the website or by searching the Google Play or Apple App stores for MHRA Yellow Card.
Notes to editors?
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The Marketing Authorisation was granted on 3 November 2023 to Mirati Therapeutics B.V.
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More information can be found in the Summary of Product Characteristics and Patient Information leaflets which will be published on the MHRA Products website within 7 days of approval.
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For more information on lung cancer, see: Lung cancer - NHS (www.nhs.uk)
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For media enquiries, please contact the newscentre@mhra.gov.uk, or call on 020 3080 7651 (Mon-Fri 08:30-17:00).
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The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe.? All our work is underpinned by robust and fact-based judgements to ensure that the benefits justify any risks.?
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The MHRA is an executive agency of the Department of Health and S