The development of combinations
of investigational agents for cancer gained steam in 2009 with a deal between Merck
& Co. Inc. and AstraZeneca
plc. At least six more companies
have joined forces since and many combination studies are underway; but there
is still work to be done to speed development, including earlier vetting of
candidate combinations, greater access to early-stage compounds and increased
use of adaptive trials.
The pace has quickened in the
face of the known hurdles to combining two novel agents: companies are hesitant
to do so until they can properly assess the efficacy and toxicity of each agent
separately. Partnerships with institutions can be delayed by institutional
review boards. And FDA has not entirely resolved uncertainty about the
regulatory requirements for such combinations.