Marketing Approvals of Anticancer Drugs in Europe
Author Information
Author(s): Apolone G, Joppi R, Bertele' V, Garattini S
Primary Institution: Istituto di Ricerche Farmacologiche Mario Negri, Milan, Italy
Hypothesis
The study evaluates the performance of regulatory agencies in approving new anticancer drugs and suggests improvements.
Conclusion
The current regulatory guidance for anticancer drugs needs revising to ensure better evaluation of their real benefits.
Supporting Evidence
- 48 clinical studies were used as the basis for approval of 27 different indications.
- Phase III randomised comparative trials are generally required for marketing authorisation.
- Most new anticancer agents are approved based on small single-arm trials.
Takeaway
This study looks at how new cancer drugs are approved in Europe and says we need to be more careful to make sure they really help patients.
Methodology
The study analyzed regulatory documents and approval data for anticancer drugs from January 1995 to December 2004.
Potential Biases
The data used came from non-standardized documents, which may introduce bias.
Limitations
The evaluation only pertains to anticancer drugs approved by EMEA and does not include drugs approved through other procedures.
Digital Object Identifier (DOI)
Want to read the original?
Access the complete publication on the publisher's website