UK MHRA Grants Marketing Authorization To Astra Zeneca’s Capivasertib

UK MHRA Grants Marketing Authorization To Astra Zeneca’s Capivasertib

By, Admin 19 July 2024

UK MHRA grants marketing authorization to Astra Zeneca’s capivasertib to treat patients with advanced breast cancer

Overview

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved the medicine capivasertib (Truqap) for patients with advanced hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative breast cancer which has one or more abnormal “PIK3CA”, “AKT1”, or “PTEN” gene, and does not respond to other anti-hormonal-based therapies.

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

Capivasertib: AKT Inhibitors

  • 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.

Combination Therapy

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.

Trial Behind Approval

  • 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.

Side Effects

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.

In Case of Any Complaints

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.

MHRA Approval

  • This product was approved under the MHRA’s International Recognition Procedure (IRP). Applications under IRP 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 an ‘Eligibility Checker’ tool on 20 November 2023.

About MHRA

  • 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.

Optimize Your trial insights with Clival Database.

Are you exhausted from the uncertainty of trial insights pricing? Clival Database ensures the clarity in the midst of the global scenario for clinical trials to you.

Clival Database is one of the best databases that offers an outstanding number of clinical trial data in terms of 50,000+ molecules and from primary regulatory markets as well as new entrants like Indian and Chinese markets.

With Clival, you get accurate positioning of historical sales data, patent database, company profiling, safety & efficacy, and prediction of launch of new innovative molecules helping you to align your research and driving down the cost.

To add value, we further break down our analytics for you so that improving your operational effectiveness; optimizing your clinical trials; and offering you accurate and high-quality data at lowest possible prices becomes possible.

Elevate your trial success rate with the cutting-edge insights from Clival database.

Check it out today and make more informed sourcing decisions! Learn More!