Alpelisib

Alpelisib, sold under the brand name Piqray, is a medication sold by Novartis and used to treat certain types of breast cancer.[1] It is used together with fulvestrant.[1] It is taken by mouth.[1]

Alpelisib
Clinical data
Trade namesPiqray
Other namesBYL719
AHFS/Drugs.comMonograph
MedlinePlusa619036
License data
Pregnancy
category
  • US: N (Not classified yet)
    Routes of
    administration    		By mouth
    ATC code
    Legal status
    Legal status
    Identifiers
    CAS Number
    PubChem CID
    PubChem SID
    DrugBank
    ChemSpider
    UNII
    ChEBI
    ChEMBL
    CompTox Dashboard (EPA)
    ECHA InfoCard100.233.704
    Chemical and physical data
    FormulaC19H22F3N5O2S
    Molar mass441.47 g·mol−1
    3D model (JSmol)

    Common side effects include high blood sugar, kidney problems, diarrhea, rash, low blood cells, liver problems, pancreatitis, vomiting, and hair loss.[1] It is an alpha-specific PI3K inhibitor.[1][2] It was approved for medical use in the United States in May 2019.[1]

    Medical uses

    In the European Union alpelisib will be indicated in combination with fulvestrant for the treatment of postmenopausal women, and men, with hormone receptor (HR)‑positive, human epidermal growth factor receptor 2 (HER2)‑negative, locally advanced or metastatic breast cancer with a PIK3CA mutation after disease progression following endocrine therapy as monotherapy.[3]

    History

    In May 2019, alpelisib was approved in the United States for use in combination with the 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 following progression on or after an endocrine-based regimen.[1]

    The U.S. Food and Drug Administration (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.[1]

    The efficacy of alpelisib was studied in the SOLAR-1 trial (NCT02437318), a randomized trial of 572 postmenopausal women and men with HR-positive, HER2-negative, advanced or metastatic breast cancer whose cancer had progressed while on or after receiving an aromatase inhibitor.[1][4]

    The FDA granted the application for alpelisib priority review designation and granted approval of Piqray to Novartis. The FDA granted approval of the therascreen PIK3CA RGQ PCR Kit to Qiagen Manchester, Ltd.[1]

    On 28 May 2020, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product alpelisib (Piqray), intended for the treatment of locally advanced or metastatic breast cancer with a PIK3CA mutation.[3] The applicant for this medicinal product is Novartis Europharm Limited.[3]

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    References
    1. "FDA approves first PI3K inhibitor for breast cancer". U.S. Food and Drug Administration (FDA) (Press release). 24 May 2019. Archived from the original on 25 November 2019. Retrieved 29 May 2019. This article incorporates text from this source, which is in the public domain.
    2. André F, Ciruelos E, Rubovszky G, Campone M, Loibl S, Rugo HS, et al. (May 2019). "PIK3CA-Mutated, Hormone Receptor-Positive Advanced Breast Cancer". The New England Journal of Medicine. 380 (20): 1929–1940. doi:10.1056/NEJMoa1813904. PMID 31091374.
    3. "Piqray: Pending EC decision". European Medicines Agency (EMA). 28 May 2020. Retrieved 23 July 2020. Text was copied from this source which is © European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
    4. "Drug Trials Snapshots: Piqray". U.S. Food and Drug Administration (FDA). 14 June 2019. Archived from the original on 25 November 2019. Retrieved 24 November 2019. This article incorporates text from this source, which is in the public domain.
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