The FDAnews Daily Drug Bulletin notes that EMA is still working on guidelines to update trial guidance for cancer drugs. The EMA issued a guidance paper describing the issues involved and their recommended course.
Problem statement
One third of new therapies in clinical development are geared toward cancer treatment reflecting a need for better treatments and a better understanding of the biology. We need an update approach with regard to inclusion criteria and and end points for exploratory and confirmatory studies.
Discussion
To be most effective, we need to identify which patients will most likely respond to treatment. There is a need to identify serum biomarkers to identify this responder patient population. However, it is also recognized that tumor biopsies will also continue to play a central role in identifying these patients. A discussion is needed to how to use and interpret the data from these sources.
Classic cytoxic compounds show a more understandable relationship between response rate (ORR), progression-free survival (PFS) and survival (OS). This appears to not be the case as frequently with targeted compounds. To what extent this pattern may differ comparing classes of compounds is not well understood.
Additonally, the use of PFS or OS as primary endpoints will be revisited. Tumor vaccines and other immune therapy approaches need further development. There is also a need to expand the section on disease specific guidance and the paragraph about quality of life/patient reported outcome.
Timetable
A draft revision of the CHMP guideline will be available 9 months after adoption of the Concept Paper. This will be released for 6 months external consultation and finalized 6 months later. NOTE: The Concept Paper was dated July 2010.
Posted by Bruce Lehr October 13th 2010.
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