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Two New Personalized Medicines Approved by FDA So Far in 2015

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I received a marketing circular last week from the organizers of the 2016 Personalized Medicine World Conference that included a message from the conference chair, Atul Butte, who made the following statement:

“The high volume of targeted drugs recently approved by the FDA – four in July alone – clearly indicates an era of therapeutics based on extensive molecular and translational comprehension of drug targets and their associated molecular pathways. This knowledge enables the path to personalized medicine through the use of patient stratification biomarkers.”

I like this statement because it draws a connection between targeted therapeutics and personalized medicine, but acknowledges that this connection takes the form of a path and that the two ideas are not synonymous.

Targeted therapeutics, drugs that act directly upon a specific molecule, are an advanced and exciting form of therapy that require significant understanding of the molecular pathways that impact a disease. Unless such drugs target a specific genetic mutation or proteomic presentation they are are not, however, part of personalized medicine. And indeed most targeted therapeutics are in fact given to entire patient populations.

To further draw out this distinction I thought it would be interesting to find out how many of the drugs approved so far in 2015 include companion diagnostic biomarkers in their drug labels, and so reviewed the labels of the 70 drugs that had been approved through August.

Two drugs released this year include companion diagnostic biomarkers:

• palbociclib is a kinase inhibitor developed by Pfizer that is indicated for ER-positive/Her2-negative breast cancer patients;

• brexpriprazole is a psychiatric drug developed by Otsuka Pharma with special indications for CYP2D6 Poor Metabolizers.

The latter biomarker falls into a category that I am have been interested in for some, that being the metabolizing enzymes which are recommended for testing in many drug labels. Look for further analysis of these biomarkers in a future post.