FDA approves first PI3K inhibitor for breast cancer

PIK3CA, the gene that encodes the PI3K protein is one of the most frequently mutated gene in breast cancer and implicated in a number of pathways that leads to the initiation and progression of oncogenic pathways. On May 24, 2019, the U.S. Food and Drug Administration approved Piqray (alpelisib, Novartis), to be used in combination with the FDA-approved endocrine therapy fulvestrant, to treat advanced or metastatic breast cancer who are PI3CA-mutated. This is another good example of the healthcare industry moving towards a more targeted-approach when it comes to drug therapy. Moving forward, we expect to see more of these “companion diagnostic test + targeted drug” combos to be made available for patients to further “personalize” treatment regimens.