FDA approves Ppelisib to work with Fulvestrant to treat breast cancer patients

recently, the United StatesThe FDA(http://approve disapprove of the Piqray pill, in conjunction with the Endocrine TherapyDrug(http://Fulvestrant, to treat patients with premenopausal women and men with specific advanced or metastatic breast cancerthese patients were hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER-2) negative and carrying PIK3CA mutations, and progressed during or after endocrine therapyThis is also the first PIK3 inhibitor approved by the FDAAt the same time, the FDA also approved a companion diagnostic test of therascreen PIK3CA
reagent(http://box for PIK3CA mutations in tissue or liquid biopsiesPatients who tested negative for the thrascreen test using a liquid biopsy should receive a tumor biopsy to identify the PIK3CA mutationA randomized clinicaltrial(http:// called SOLAR-1 validated the efficacy of Piqray The trial recruited 572 postmenopausal women and men with HR-positive, HER-2-negative advanced or metastatic breast cancer, whose tumors progressed during or after receiving aromatase inhibitors results showed that patients with PIK3CA mutations with additional Piqray in the treatment of fluorovis group, significantly extended the non-progressive survival (PFS), with a median PFS of 11 months and 5.7 months, respectively There was no significant difference in PFS in patients without PIK3CA mutation 　　Common side effects Piqray in safe health include: elevated blood sugar levels, increased creatininine, diarrhea, rash, decreased concentration cell count in the blood, increased liver enzymes, nausea, fatigue, low red blood cell count, increased lipase secretion by the pancreas, decreased appetite, oral inflammation, vomiting, weight loss, low calcium content, aPTT extension (i.e long-term blood clotting time than normal) and hair loss