FDA authorizes blood test for risk assessment of hereditary cancers

with capivasertib and fulvestrant and in 0.3% of patients treated with fulvestrant and a placebo, and diarrhea occurred in 9.3% and 0.3%, respectively.Treatment discontinuation due to adverse events was reported in 13.0% and 2.3% of patients, respectively.The lead author of the phase 3 CAPItello-291 study, Nicholas Turner, MD, PhD, a professor of molecular oncology at the Institute of Cancer Research in London, England, says that he is "delighted that the FDA has approved capivasertib for patients with the most common type of advanced breast cancer" with the genetic mutations in PIK3CA/AKT1/PTEN, and he hopes that Europe and the United Kingdom will be next to approve it."This means that patients [with breast cancer] with this kind of advanced disease that has progressed on other treatments will have an additional, targeted treatment option that will help keep their cancer from progressing longer," he said in a news article from the Institute of Cancer Research. 3he FDA approval mandates the use of an FDA-approved test to provide the tumor profiling to identify which patients with breast cancer are eligible for treatment with the combined capivasertib-fulvestrant regimen. 1 In November 2023, the FDA approved the FoundationOne CDx assay as a companion diagnostic device in this setting. 1,4