Adagrasib in Europe: When will it be available and how to avoid waiting
Last updated: 31 January 2024
You can legally access new medicines, even if they are not approved in your country.
Learn howThe year 2023 has been challenging for NSCLC patients in Europe. The EMA rejected Krazati (adagrasib)'s marketing authorization application in July, reducing the number of second-line treatment options available for patients with the KRAS G12C mutation 1.
However, a reevaluation led the European regulator to change their mind and Krazati (adagrasib) finally got its EMA approval in November 2023 2.
What does adagrasib's EMA approval mean for lung cancer patients in Europe? And when will the medicine be available on the European market?
What is adagrasib for?
Krazati (adagrasib) is a second-line treatment for adults with advanced non-small cell lung cancer (NSCLC). The medicine is specifically designed to target a particular mutation known as KRAS G12C.
The mutation can cause the production of an altered protein which triggers uncontrolled growth in cancer cells. Adagrasib attaches itself to this altered protein and inactivates it, thus slowing the growth and spread of cancer cells 2.
Adagrasib's EMA approval: How "no" turned to "yes"
Krazati's marketing authorization was initially rejected. The CHMP justified its decision with insufficient proof that the medicine would lead to longer survival compared to already approved medicines. Specifically, this was based o the CodeBreak 200 study, which compared adagrasib with sotorasib 2.
However, when reassessing the data submitted by Krazati's manufacturer, the CHMP concluded that comparing adagrasib to sotorasib may not have been a relevant approach.
Further clinical trial data pointed to the benefits that Krazati may offer for NSCLC patients. One main benefit was its safety profile, and the other - its mode of administration (oral tablets). Compared to docetaxel intravenous infusions - the standard of second-line care for advanced NSCLC - Krazati was considered to provide advantages for patients 2.
On the basis of this reexamination, adagrasib received conditional marketing authorization in Europe.
When will adagrasib be available in Europe?
Adagrasib's EMA approval doesn't mean it's now available on the market. Typically, it takes about 67 days for the CHMP's recommendation to become an official authorization 3. Since Adagrasib was approved in November 2023, its authorization in Europe should become complete by early February 2024.
However, even after it's officially authorized, adagrasib won't be available on the market in Europe immediately. Each member state will need to go through its own process of price negotiation, and make decisions about local reimbursements, before the medicine can be launched on the local markets.
How long this process takes can vary greatly from one country to the next. The EU average for launching oncological treatments is 545 days, with Germany typically the fastest (100 days), and Romania the slowest (964 days) 4.
Based on these timelines, adagrasib will likely only be available on (some) European markets towards the end of 2024 at the earliest.
How to access adagrasib before it's available across Europe
Waiting is not always an option for NSCLC patients. That's why it's good to know that you don't have to wait.
If your doctor is of the opinion that adagrasib could benefit you, you could buy the medicine immediately for your personal use. This is made possible by the Named Patient Import regulation, and applies to most countries in the world.
To be able to buy adagrasib as an Individual Named Patient, you will first need a prescription from your doctor.
Do you have a prescription already? Send it to us and let us help you access the treatment you need when you need it - now.
References:
- Kansteiner, Fraiser. Mirati's flagship KRAS inhibitor Krazati gets rebuffed in Europe. Fierce Pharma, 21 July 2023.
- Krazati_2023-11_Q-and-A on re-exam - positive opinion. European Medicines Agency, 10 November 2023.
- Presentation - Centralised procedure at the European Medicines Agency. European Medicines Agency, Accessed 31 January 2024.
- EFPIA Patients W.A.I.T. Indicator 2021 Survey. EFPIA, Accessed 31 January 2024.
