The number of drugs with companion diagnostics for solid and heme malignancies has grown dramatically year on year, increasing five-fold over the last 10 years to around 50 at the end of 2022.
The table below shows FDA approvals for the last 5 years. It is split by new molecular entities, in blue, and additional indications for previously approved drugs in orange. It clearly shows the number of indication extensions has outnumbered first approvals of new drugs every year.
These are drugs which have been developed to target an aberration in a gene product in a specific tumor type. Herceptin for HER2 positive breast cancer is the obvious example; first approved by the FDA in 1998 with additional breast cancer indications added from 2006, it only moved in 2010 into a different tumor histology (gastric cancer – HER2 positive gastric cancer).
This can be contrasted with Enhertu. It was first approved for unresectable or metastatic breast cancer after a prior anti-HER2-based regimen in 2019, approved in gastric cancer in January 2021, and another two breast cancer indications plus nonsmall cell lung cancer (NSCLC) last year. That is three different tumor locations in 4 years.
Precision medicine: the growing complexity of decision-making
However, until recently, development of these products was histology dependent – i.e., tumor type by tumor type. As these drugs have launched, we have seen the division of tumor types into subtypes defined by biomarker status (e.g., NSCLC may be divided by EGFR, ALK, ROS or KRAS status with multiple different therapies approved for each).
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