Capivasertib's EMA approval: When is it coming, and what to do in the meantime?

Last updated: 14 February 2024

Capivasertib's EMA approval: When is it coming, and what to do in the meantime?

You can legally access new medicines, even if they are not approved in your country.

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In recent years, there have been significant advancements in the treatment of HR-positive, HER2-negative metastatic breast cancer. Including the approval of medicines such as Kisqali (ribociclib), Piqray (apelisib), and Ibrance (palbociclib). However, these treatments may eventually lead to resistance. The recent approval of Truqap (capivasertib) offers hope for breast cancer patients seeking alternative options.

At this moment, Truqap is only approved in the USA, leaving many breast cancer patients in Europe and the UK eager to know when it will be available to them. Here's everything you need to know about capivasertib's EMA approval status and MHRA approval prospects.

What is capivasertib used for?

Truqap (capivasertib) is prescribed in combination with fulvestrant to treat adults diagnosed with HR-positive, HER2-negative locally advanced or metastatic breast cancer exhibiting specific genetic alterations in PIK3CA/AKT1/PTEN 1. Capivasertib's active ingredient targets the AKT protein, crucial for cancer cell growth. By inhibiting AKT's activity, capivasertib aims to slow down tumor growth 2.

Furthermore, capivasertib is under investigation for potential applications in various other cancers. These include prostate cancer, B-cell non-Hodgkin's lymphomas, multiple myeloma, metastatic triple-negative breast cancer, HER2-positive breast cancer, endometrial cancer, non-small cell lung cancer, and more 3. The extent of its role in cancer treatment will become clearer as additional research and clinical trial data emerge.

Capivasertib EMA approval: What's the status?

As of February 2024, Truqap (capivasertib) is not yet approved by the EMA. Its marketing authorization application has been in review since 18 May 2023. Typically, applications are reviewed within 210 days, meaning that the CHMP is likely to share its opinion in early 2024. If positive, capivasertib's EMA approval should become official within 67 days afterwards.

Is capivasertib approved in the UK?

Capivasertib is not currently approved in the UK. There is no timeline indication for the MHRA or NICE evaluation of the medicine. This implies that patients with breast cancer in the UK may face challenges in accessing Truqap in the foreseeable future.

How to safely access capivasertib before its EMA approval

The absence of EMA approval for capivasertib does not have to mean a long waiting time for patients in Europe or the UK. Safe alternatives exist for accessing capivasertib before local approval.

One option is to find and join a clinical trial involving capivasertib. The other option is to buy capivasertib immediately as an Individual Named Patient.

Join a capivasertib clinical trial

To get quick access to capivasertib in Europe or the UK, you can try joining an ongoing clinical trial. It can take some effort finding one, but it is possible. In order to participate in a clinical trial, you must meet the eligibility criteria. You will also need your treating doctor's support to be able to participate. In all cases, you should be aware that you might be on a placebo group in the trial.

Here are some good places to start looking for ongoing capivasertib clinical trials:

  • ClinicalTrials.gov: A comprehensive database of US clinical trials. Select trials are open to international participants, including the SERENA-1 and CAPItello-292 trials, available in multiple European countries.
  • EUClinicaltrials.eu: This database contains all clinical trials in the European Union. Currently, it contains limited information on trials launched before 31 January 2022. For those trials, you can refer to the EU Clinical Trials Register.
  • myTomorrows and FindMeCure: These organizations support patients worldwide in locating suitable clinical trials.

Buy capivasertib as an Individual Named Patient

Even if a medicine is not yet approved or available in your country, you can buy and import it for your personal use. This is stipulated under the Named Patient Import regulation and applies to most countries in the world. 

If you want to access capivasertib before its EMA approval or MHRA approval, this is your quickest option.

To buy capivasertib immediately, you will need a prescription from your treating doctor, who assumes responsibility for the treatment. Specific additional documentation may be necessary based on your country's regulations.

 

Buy capivasertib

Do you want to use the Individual Named Patient Import regulation to buy capivasertib before its approval in Europe or the UK? Send your prescription to our team at Everyone.org and we will support you with buying capivasertib immediately.

 

References:

  1. HIGHLIGHTS OF PRESCRIBING INFORMATION, Accessdata.fda.gov, Accessed 15 January 2024.
  2. Truqap: Side Effects, How It Works, and More. Breastcancer.org, 21 December 2023.
  3. Capivasertib by AstraZeneca for Metastatic Breast Cancer: Likelihood of Approval. Pharmaceutical Technology, Accessed 15 January 2024.
  4. Capivasertib + CDK4/​6i + Fulvestrant for Advanced/​Metastatic HR+/​HER2- Breast Cancer (CAPItello-292) (CAPItello-292). ClinicalTrials.gov, Accessed 15 January 2024.
  5. Study of AZD9833 Alone or in Combination in Women With Advanced Breast Cancer. (SERENA-1). ClinicalTrials.gov, Accessed 15 January 2024.
  6. EFPIA Patients W.A.I.T. Indicator 2021 Survey. EFPIA, Accessed 14 February 2024.