World Cancer Day 2023

On #WorldCancerDay, I would like to highlight some exciting insights on #cancer medicines regulation and development at the European Medicines Agency (EMA).

For many years now, #oncology has been the therapeutic area that has had most new approvals. In 2022 alone, our Human Medicines Committee, the CHMP, approved 23 new cancer medicines for use in the EU. This is not a trivial number - it corresponds to 26% of all the medicines approved by EMA last year, and it shows the huge investment made by researchers and developers in oncology. Since its creation, back in 1995, EMA has approved over 190 cancer medicines.

Because this is an area where top innovation and scientific progress happen as we speak, we have decided that, in 2023, we will use cancer as a pathfinder to improve medicines evaluation overall, by applying some of the lessons we have learnt during the pandemic. ?We want to become more flexible and efficient, thus reducing the time needed to assess new medicines, while keeping ?the same high-quality standards and robust assessments.?

We will explore if our ‘Priority Medicines’ scheme (PRIME), which supports the development of medicines that target an unmet medical need, could be further improved as a pilot for oncology products. We will build on our relationships with health technology assessment bodies in this area and we will also enhance our international collaboration.

These and some of the other areas we are exploring should also help ?patients to access treatments faster.

As you know, I am a firm believer in science. And, luckily, we are living in times of huge scientific advances! We have all witnessed the fast development of COVID-19 vaccines based on RNA technology, which have saved so many lives in the EU.

In view of the unprecedented progress made in the last three years, we are exploring the opportunities that RNA technology could offer for the treatment of other diseases, such as cancer.

This was precisely the theme of a conference that my colleagues organised earlier this week to discuss the development of RNA-based medicines. Let me share some highlights of the conference, specifically related to how RNA technology could benefit cancer treatments:

• mRNA-based cancer treatments have been tested in small trials for nearly a decade, with some promising early results. However, they did not translate into new drug applications.
• There are currently several cancer treatments under development, including in phase 2 clinical trials. We are eager to see if their effects will be confirmed at a larger scale, leading to new drug applications.
• Research on RNA-based technology and other approaches, including new advanced therapies, hold promising prospects for the treatment of cancer. To be successful, we need to continue working closely together and increase synergies wherever possible.

Based on the positive outcome of this week’s conference, I would like to confirm my commitment to continuing to support a multi-stakeholder dialogue, involving cancer researchers, developers, funding organisations, patients, and regulators as well as other stakeholders. Only by joining our forces we can accelerate the development of new life-saving cancer medicines!