The CDDF & ESMO educational session on “Regulatory Challenges in Clinical Cancer Drug Development” took place on 16 September 2024 at ESMO 2024. In this session, Aaron E. Sosa Mejia (Danish Medicines Agency) and Audrey Wolf (EFPIA) gave presentations followed by a Q&A discussion moderated by Ruth Plummer (CDDF) and Teresa M. Amaral (Tuebingen University). Here are key takeaways from the meeting:
- Aaron Sosa Meija (Danish Medicines Agency, CHMP member) outlined the process and timelines for CHMP approvals and illustrated to the audience how to navigate the EMA website to find current SmPCs and assessment documents.
- The differences between full and conditional marketing approvals were discussed, with annual review of the later involving assessment of progress to meet conditions requested.
- Cost is not considered as part of a CHMP assessment. This would potentially introduce bias to assessment of the scientific outcomes and patient benefit.
- The major trials area of challenge is the neo-adjuvant/adjuvant studies as pathological endpoints are not considered sufficiently validated, and the authorities would also like to see evaluation of the various components of treatment (neoadjuvant, surgery and adjuvant) so 3 arm studies would be expected to be the norm.
- Audry Wolf (EFPIA) outlined the challenges from the IVDR process, the key one being that this is decentralised, so there is a lack of coordination between member states, unlike the CHMP process.
- EFPIA has carried out a recent member survey exploring the impacts of the new regulations, and highlighted there were delays in trial set up and also loss of trial activity in EU states to other global areas.
- Response to these challenges has been rapid with the establishment of the COMBINE programme by the EU Commission, bringing together all stakeholders to harmonise the new process.
🔶To watch a key takeaways video, click the link: https://youtu.be/N5gyQwxS4LkÂ
🔶For speaker presentations, visit the ESMO member page: https://oncologypro.esmo.org/Â