FDA guides on molecular targeted therapies beyond cancer

FDA has released two new draft guidance documents that are intended to help extend some of the scientific and regulatory advances that have been made in targeted therapies for cancer to other diseases. FDA has previously signaled that it will approve cancer drugs like Keytruda pembrolizumab from Merck & Co Inc. (NYSE:MRK) for tissue-agonistic indications; now it is indicating that the agency is outlining a regulatory approach for applying similar strategies to other types of diseases.

The approach is a departure from defining diseases based on tissue of origin or symptoms, and towards creation of personalized medicines that capitalize on genomics data...