GovWire

The active substance capivasertib is part of a group of medicines called AKT inhibitors. It blocks the effects of proteins called ATK Kinases, which enable cancer cell growth and multiplication. By blocking their action, capivasertib can reduce the growth and spread of the advanced breast cancer and help to destroy cancer cells.

Capivasertib is given with fulvestrant, a hormonal therapy for the treatment of advanced breast cancer. Capivasertib is taken orally at a starting dose of 400 mg twice a day for four days followed by three days of rest, then repeated.

The application for approval was supported by evidence obtained via a clinical trial of 708 patients with locally advanced or metastatic HR-positive, HER2-negative breast cancer, of which 289 patients had tumours with an abnormal PIK3CA, AKT1 or PTEN gene. Patients were given either capivasertib or a placebo, both in combination with fulvestrant.

During clinical trials, patients given capivasertib experienced an average 7.3 months with the cancer not progressing versus 3.1 months for patients who were given placebo.

Potential side effects of this medicine include high blood sugar, diarrhoea, rash and other skin drug reactions, urinary tract infection, low level of haemoglobin in blood, loss of appetite, nausea, vomiting, mouth sores or ulcers with gum inflammation, itching, and tiredness.

As with any medicine, the MHRA will keep the safety and effectiveness of Truqap under close review.

Anyone who suspects they are having a side effect from this medicine are encouraged to talk to their doctor, pharmacist or nurse and report it directly to the Yellow Card scheme, either through the website (https://yellowcard.mhra.gov.uk/) or by searching the Google Play or Apple App stores for MHRA Yellow Card.

Notes to editors?

• The new marketing authorisation was granted on 17 July 2024 to Astra Zeneca UK Limited.

• More information can be found in the Summary of Product Characteristics and Patient Information leaflets which will be published on theMHRA Products websitewithin 7 days of approval.

• This product was approved under the MHRAs International Recognition Procedure (IRP). Applications underIRP can be received via the MHRA website. Time horizons for authorisations are set at 60 to 110 days considerably shorter than the current 150-day time horizon for applications. To further streamline the IRP application process, the MHRA launched anEligibility Checker toolon 20 November 2023.

• 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.

• The MHRA is an executive agency of the Department of Health and Social Care.

• For media enquiries, please contact thenewscentre@mhra.gov.uk, or call on 020 3080 7651.

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