Biomarkers in Cancer Approvals: New Opportunities and Challenges

The FDA recently approved Keytruda and Vitrakvi, two cancer drugs targeting biomarkers without reference to the site of the disease. Defining cancer in terms of biomarkers alone may require us to rethink the design of clinical trials and raises challenges for the traditional FDA approval process. What is the future of these so-called “tumor-agnostic” therapies, and how will they be translated into effective treatment options in cancer and other diseases? More info here.