In a landmark decision today, the Medicines and Healthcare products Regulatory Agency (MHRA) approved capivasertib (Truqap) for patients with advanced hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative breast cancer.
This approval marks a significant advancement for patients with specific genetic alterations who have not responded to other treatments.
Introduction
The Medicines and Healthcare products Regulatory Agency (MHRA) has approved capivasertib (Truqap) for advanced hormone receptor-positive, HER2-negative breast cancer with specific genetic mutations.
This decision, announced on 17 July 2024, provides new hope for patients who have not responded to other therapies.
A New Hope for Breast Cancer Patients
Capivasertib represents a breakthrough for patients with advanced breast cancer, specifically those with abnormal PIK3CA, AKT1, or PTEN genes. This new treatment, developed by Astra Zeneca UK Limited, targets patients who have not seen success with other anti-hormonal therapies.
Mechanism of Action
Capivasertib is part of a group of medicines called AKT inhibitors. It works by blocking the effects of proteins called ATK kinases, which enable cancer cell growth and multiplication.
By inhibiting these proteins, capivasertib can reduce the growth and spread of advanced breast cancer and help destroy cancer cells.
Clinical Trials and Efficacy
The approval was based on robust evidence from a clinical trial involving 708 patients with locally advanced or metastatic HR-positive, HER2-negative breast cancer.
Among these patients, 289 had tumors with abnormal PIK3CA, AKT1, or PTEN genes. They received either capivasertib or a placebo, both in combination with fulvestrant, a hormonal therapy.
Treatment Group |
Average Progression-Free Survival (months) |
|---|---|
| Capivasertib + Fulvestrant | 7.3 |
| Placebo + Fulvestrant | 3.1 |
The results were promising. Patients treated with capivasertib experienced an average of 7.3 months without cancer progression, compared to 3.1 months for those on the placebo. This significant improvement in progression-free survival highlights the potential of capivasertib in treating this patient population.
Important Facts
- Approval Date: 17 July 2024.
- Developed by: Astra Zeneca UK Limited.
- Target Patients: Advanced HR-positive, HER2-negative breast cancer with abnormal PIK3CA, AKT1, or PTEN genes.
- Combination Therapy: Capivasertib is administered with fulvestrant.
- Dosage: 400 mg twice a day for four days, followed by three days of rest.
Administration and Dosage
Capivasertib is administered orally at a starting dose of 400 mg twice a day for four days, followed by three days of rest, in repeated cycles. It is given alongside fulvestrant to enhance treatment efficacy.
Potential Side Effects
Like all medications, capivasertib comes with potential side effects. These include high blood sugar, diarrhea, rash and other skin reactions, urinary tract infection, low hemoglobin levels, loss of appetite, nausea, vomiting, mouth sores or ulcers, itching, and fatigue.
The MHRA will continuously monitor the safety and effectiveness of Truqap.
Post-Approval Monitoring and Reporting
Patients experiencing side effects are encouraged to report them to their healthcare provider and through the Yellow Card scheme via the MHRA website or the MHRA Yellow Card app available on Google Play and Apple App stores.
Regulatory and Marketing Information
The new marketing authorization for capivasertib was granted to Astra Zeneca UK Limited. Detailed information can be found in the Summary of Product Characteristics and Patient Information leaflets, which will be published on the MHRA Products website within seven days of approval.
This product was approved under the MHRA’s International Recognition Procedure (IRP), which streamlines the approval process, reducing the time horizon for authorizations to 60-110 days, compared to the current 150-day timeframe.
To further simplify the IRP application process, the MHRA launched an ‘Eligibility Checker’ tool on 20 November 2023.
Consider This
Capivasertib represents a significant advancement in the treatment of HR-positive, HER2-negative advanced breast cancer, particularly for patients with specific genetic alterations.
Its approval expands treatment options and underscores the importance of molecular testing in guiding personalized treatment decisions for advanced breast cancer.
The MHRA’s decision brings new hope and a promising future for many patients battling this challenging disease.
Sources: THX News, New England Journal of Medicine, Targeted Oncology, Cancer Network & Medicines and Healthcare products Regulatory Agency.
