Fda approves Piqray pills in combination with fullvestrant therapy

recently, the U.S. Food and Drug Administration (FDA) announced that Piqray (alpelisib) pills in combination with fullvestrant therapy have been approved for the treatment of hormone-positive (HR), human skin growth factor 2 (HER2) negative, PIK3CA mutation of advanced or metastasis breast cancer.
the pills were approved for use in men and post-menstrual women, who progressed after receiving endocrine therapy.The drug was also approved together with the accompanying diagnostic test therascreen PIK3CA RGQ PCR kit, which detects PIK3CA mutations in tissue or liquid biopsies. According to the manufacturer's prescription information, Piqray's recommended dose is 300 mg (two 150 mg tablets) once a day.
approval was based on data from the SOLAR-1 trial, which included 572 men and post-menoanthiotic women who had HR-positive, HER2-negative, advanced or metastasis breast cancer and progressed after treatment with aromatase inhibitors.In patients with tumors with PIK3CA mutations, the medium non-progression survival of patients treated with piqray and fullvestrant was 11 months, while the medium non-progression survival of patients treated with fullvestrant alone was only 5.7 months. Patients treated with Piqray and fullvestrant had a total efficiency of 35.7 percent and 16.2 percent, respectively, compared to those treated with fullvestrant alone.
safety:
clinicians should monitor patients taking Piqray for severe allergic reactions and should warn patients of possible severe skin reactions. Patients with a history of severe skin reactions should disable Piqray, such as Stevens-Johnson syndrome, polygonal erythema, or toxic epithetical necrosis.
because patients taking Piqray are at risk of severe hyperglycemia, clinicians should optimize blood sugar control by examining patients with peri-abdominal blood sugar and hemoglobin A1c. Patients using Piqray also reported severe pneumonia/interstitiotic lung disease and diarrhea, and clinicians were advised to monitor these conditions during treatment.
piqray was approved by Novaral, while thetheerascreen PIK3CA RGQ PCR kit was approved for QIAGEN Manchester Ltd. (Drug Information Network)