Tissue Agnostic - Genomic Based Treatment – A Paradigm Shift in Cancer Treatment


FDA approval of Vitrakvi shifts cancer treatment toward genomic testing-creates new challenges for doctors and patients.

by Dr. C.H. Weaver M.D. 11/27/2018

The US Food and Drug Administration (FDA) on Monday approved a new precision cancer medicine Vitrakvi (larotrectinib) for the treatment of adult and pediatric solid tumors that have a targetable biomarker known as a neurotrophic receptor tyrosine kinase (NTRK) gene fusion.

This represents a major paradigm shift in how doctors and their patients will need to think about cancer treatment. Until recently we thought of breast cancer cells as having a unique biomarker target that could be treated with a precision cancer medicine. Now, in effect, the biomarker defines the cancer rather than the organ where the cancer began.

Vitrakvi is the second “tissue agnostic” drug approved for the treatment of cancer this year. The first “tissue agnostic” FDA approval was for Keytruda (pembrolizumab) for adult and pediatric patients with unresectable or metastatic, microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors that have progressed following prior treatment.

According to the FDA Commissioner Dr. Scott Gottlieb, M.D. "Today's approval marks another step in an important shift toward treating cancers based on their tumor genetics rather than their site of origin in the body.”

The shift away from organ specific treatments creates some unique challenges for cancer patients and their doctors and provides hope to many individuals with hard to treat cancers who can now look to genomic testing as another way to identify their available treatment options.


  1. mavendoctors.io/cancerconnect/treatment-care/fda-grants-first-tissue-agnostic-accelerated-approval-to-keytruda-0IwnMskXT0eB08cvpJG30A/
  2. mavendoctors.io/cancerconnect/treatment-care/vitrakvi-larotrectinib-fda-approved-for-treatment-of-ntrk-cancers-mReYZke1nEKjorRxMZFy_Q/