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:
This FDA approval provides another example of rapidly evolving 21st 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 21st Century oncology therapies continues to thrive.