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FDA approves first PI3K inhibitor for breast cancer |
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FDA approves first PI3K inhibitor for breast cancer
eMediNexus,  27 May 2019
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#Hematology #Obstetrics and Gynecology #Oncology #Pathology and Lab Medicine #Pharmacist

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The U.S. Food and Drug Administration approved Piqray (alpelisib) tablets, to be used in combination with the FDA-approved endocrine therapy fulvestrant, to treat postmenopausal women, and men, with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CA-mutated, advanced or metastatic breast cancer (as detected by an FDA-approved test) following progression on or after an endocrine-based regimen.

The FDA also approved the companion diagnostic test, therascreen PIK3CA RGQ PCR Kit, to detect the PIK3CA mutation in a tissue and/or a liquid biopsy. Patients who are negative by the therascreen test using the liquid biopsy should undergo tumor biopsy for PIK3CA mutation testing. (FDA, May 24, 2019)

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