# Trends in oncology marketing applications in the European Union: a five‐year systematic review

## TL;DR

This paper analyzes trends in cancer drug approvals in the EU over five years, focusing on application numbers, company size, and approval timelines.

## Contribution

The study provides a systematic review of oncology drug marketing applications in the EU over five years, highlighting trends and procedural impacts.

## Key findings

- Blood cancers were the main therapeutic indication for oncology MAAs.
- Large-sized companies submitted the majority of MAAs (72%).
- Scientific advice was requested in 92% of MAAs.

## Abstract

In the European Union, before cancer medicines containing a new active substance become available to patients, they must undergo a rigorous authorization process through the Centralized Procedure. This study examines trends in oncology Marketing Authorization Applications (MAAs) over the past 5 years. Oncology MAAs from January 2020 to January 2025 were used to collect and analyze publicly available data. The number of MAAs, therapeutic indications, company and product characteristics, scientific advice (SA), orphan designation (OD)/expedited programs, and overall procedural time were analyzed. A total of 60 MAAs were identified. During the reporting period, only three MAAs received negative opinions; however, two were reverted to positive after re-examination. Blood cancers were the main therapeutic indication. The typical profile of a MAA was as follows: a large-sized company holder (72%); monoclonal antibody (mAb) (31%); SA requested (92%); under OD at both time points: at the moment of application (60%) and at the moment of receiving the opinion by the Committee for Medicinal Products for Human Use (67% of the initial number of MAAs under OD); not granted any expedited program (57%); and with an average total procedure time of about 348 days. Additionally, procedural time analysis revealed shorter timelines for MAAs under the accelerated assessment (AA) program and those that obtained SA. Oncology MAAs have increased over the years, particularly for mAbs and blood cancer indications. Large-sized companies were the main MAA holders. Additionally, the SA and AA program might have demonstrated a positive impact in reducing procedural time.

Five-year analysis of oncology drugs in the EU with graphics on therapeutic indication, company size, and product category. Includes a Venn diagram on marketing strategies and a bar chart on procedural time.