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EMA’s Cancer ‘Pathfinder’ Project Targets Conditional Approvals, Endpoints & RWE

 
• By Ian Schofield

This second of a two-part article on the EU’s “Cancer Medicines Pathfinder” initiative looks at the trade-off between the benefits and risks of conditional drug approvals and differing perceptions of progression-free survival as a validated endpoint in cancer drug trials.

Cancer Diagnosis and disease detection or screening as a treatment for malignant cells with a biopsy or testing with a cancerous cell as an immunotherapy symbol
The EMA is targeting the development of drugs for cancer • Source: Shutterstock

Among the aims of the European Medicines Agency’s “Cancer Medicines Pathfinder” initiative are to gauge how far regulators are willing to accept the uncertainties associated with the EU’s conditional marketing authorization system, and to contribute to the ongoing debate over the use of endpoints in cancer treatment.

Also in the pipeline is a study to garner views on the use of real-world evidence in approval applications for...

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