The European Medicines Agency (EMA) and the Cancer Medicines Forum (CMF) held a workshop on 14 November 2025 to discuss how industry can support cancer treatment optimisation, focusing on dose, duration, and sequencing of oncology medicines. The meeting report, published on 14 July 2026, summarises discussions on post-marketing studies, reward mechanisms, and data sharing, with the aim of resolving uncertainties that persist after initial marketing authorisation.
The workshop, held in Amsterdam, was opened by Francesco Pignatti, EMA Scientific Adviser in Oncology, who described the event as a natural evolution of the CMF since its launch in 2022, now expanding industry engagement. He stressed that treatment optimisation addresses gaps in evidence for optimal dosing, duration, and real-world therapeutic value. Industry representatives Michael Zaiac of Daiichi-Sankyo Europe and Dominita Burcoveanu of Bayer presented the industry perspective. Burcoveanu noted that dose, duration, and treatment sequence are often not fully understood at the time of marketing authorisation, as registration trials may not capture real-world complexity. She called for pragmatic, adaptive clinical trials involving input from clinical practice, patients, and payers. Zaiac outlined the CMF's origins as a multi-stakeholder forum including academia, health technology assessment bodies, payers, and patient representatives, and highlighted its work on a framework for optimisation trials and case examples showing benefits of de-escalation strategies for patient outcomes and cost-effectiveness. He emphasised the need for randomised clinical trials rather than real-world comparisons, and for sustainable funding models including payer engagement.
The report notes that discussions also covered reward mechanisms for post-marketing studies, industry's role in supporting optimisation post-approval, and data and tissue sharing. The workshop aimed to strengthen collaboration and secure collective commitment to address these challenges. No formal decisions or consensus were reached, as the report is a selective summary for informational purposes only.