Companion Diagnostic

Co-development Drug and Companion Diagnostic: Lessons Learnt from the Development Program of Pembrolizumab (Keytruda)

by Michael Firgens

Companion diagnostics are medical devices which provide information that is essential for the safe and effective use of a corresponding drug facilitating personalized therapies in which treatment can be customized for an individual patient. It is reasonable to combine drug and companion diagnostic development, however, co-development programs must overcome regulatory hurdles and additional complexity until marketing authorization approval.

The development program of Pembrolizumab is an example for the successful co-development of a new biological drug accompanied by a companion diagnostic. Michael Firgens summarizes several lessons from the co-development of Pembrolizumab and its companion diagnostic that can be considered for future co-development programs of medicinal products.