BioCentury
ARTICLE | Product Development

Overcoming origins

Why oncology drug development will remain tissue-dependent, for now

June 8, 2015 7:00 AM UTC

The start of two large-scale trials enrolling patients whose tumors share a common molecular signature regardless of the tissue of origin reflects tremendous progress in both the understanding of cancer biology and the availability of effective targeted therapies. But oncology drug development is still very far away from breaking free from the ingrained system of classifying tumors according to the tissue of origin.

The reasons are many, including the difficulty of conducting and interpreting results from studies enrolling patients with different tumor types for which the standard of care is different, and the need to demonstrate a consistent effect across a sufficient number of tissue types that would enable regulators to conclude there is a positive benefit-risk profile in an indication defined by molecular signature alone...