Encouraging News On The Immunotherapy Front

FDA has now approved KEYTRUDA (pembrolizumab) for a second indication based on a tumor biomarker rather than the originating source of the tumor in the body.  Specifically, FDA has approved KEYTRUDA for patients with an unresectable or metastatic solid tumor with a high mutational burden (i.e, 10 or more mutations).  As part of this approval, FDA has also approved Foundation Medicine’s FoundationOne CDx as a companion diagnostic that physicians can use to identify those patients who may be eligible for KEYTRUDA based on a high tumor mutational burden.

A copy of FDA’s Press Release can be found here:

https://www.fda.gov/drugs/drug-approvals-and-databases/fda-approves-pembrolizumab-adults-and-children-tmb-h-solid-tumors

This FDA approval provides another example of rapidly evolving 21^st Century medicine and its attention not to the specific site of tumor origin but rather specific characteristics of the patient’s tumor.  This concept is sometimes referred to as tumor-agnostic because the location in the body of the originating tumor source is not relevant. 

FDA’s first tumor-agnostic approval of KEYTRUDA was in 2017 and was for patients with unresectable or metastatic solid tumors with microstatellite instability-high (MSI-H) or mismatch repair deficiency (dMMR).  Yesterday’s approval for use in patients with a high tumor mutational burden is the second.  Looking forward to seeing others as the research and development of 21^st Century oncology therapies continues to thrive.