US FDA approved the first PI3K inhibitor for the treatment of metastatic advanced breast cancer

June 3, 2019 / bioin / - the United States Food and Drug Administration (FDA) announced on Friday that the combination therapy of piqray (alpelisib) and fulvestrant was approved for the treatment of hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative, and PIK3CA mutation in advanced or metastatic breast cancer These tablets are approved for use in men and postmenopausal women whose disease progresses after receiving endocrine therapy The drug was also approved with the matching diagnostic test therascreen PIK3CA rgq PCR kit, which can detect PIK3CA mutations in tissue or liquid biopsies According to the manufacturer's prescription information, the recommended dose of piqray is 300 mg once a day (two 150 mg tablets) Approval was based on data from the solar-1 trial, which included 572 men and postmenopausal women with HR positive, HER2 negative, advanced or metastatic breast cancer who progressed after treatment with aromatase inhibitors Among the tumor patients with PIK3CA mutation, the median progression free survival of patients treated with piqray and fulvestrant was 11 months, while the median progression free survival of patients treated with fulvestrant alone was only 5.7 months The total effective rates of patients treated with piqray and fulvestrant were 35.7% and 16.2% respectively Clinicians should monitor patients who are taking piqray for severe allergic reactions and warn patients of possible severe skin reactions Piqray should be banned in patients with a history of severe skin reactions, such as Stevens Johnson syndrome, erythema multiforme or toxic epidermal necrolysis Since patients taking piqray are at risk of severe hyperglycemia, clinicians should check their fasting blood glucose and hemoglobin A1c to optimize blood glucose control Patients using piqray also reported severe pneumonia / interstitial lung disease and diarrhea, which clinicians are advised to monitor during treatment Piqray was approved by Novartis, while therascreen PIK3CA rgq PCR kit was approved by Qiagen Manchester Ltd Reference: first PI3K inhibitor approved for metric, advanced break cancer