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Home » Directories » FDA Approved Drugs » Piqray (alpelisib)

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Piqray (alpelisib)

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    General Information

    Piqray (alpelisib)is a kinase inhibitor.

    Piqray is specifically indicated for use 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, PIK3CA-mutated, advanced or metastatic breast cancer as detected by an FDA-approved test following progression on or after an endocrine-based regimen.

    Piqray is supplied as a tablet for oral administration. The recommended dose is 300 mg (two 150 mg tablets) taken orally once daily with food. For adverse reactions, consider dose interruption, dose reduction, or discontinuation. 

    Clinical Results

    FDA Approval

    The FDA approval of Piqray was based on SOLAR-1 trial, 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. Patients received either Piqray (300 mg) or placebo orally once daily on a continuous basis, plus fulvestrant (500 mg) administered intramuscularly on Cycle 1, Days 1 and 15, and then on Day 1 of every 28-day cycle. Patients received treatment until radiographic disease progression or unacceptable toxicity. Tumor assessments were performed every 8 weeks for the first 18 months and every 12 weeks thereafter. Results from the trial showed the addition of Piqray to fulvestrant significantly prolonged progression- free survival (median of 11 months vs. 5.7 months) in patients whose tumors had a PIK3CA mutation.

    Side Effects

    Adverse effects associated with the use of Piqray may include, but are not limited to, the following:

    glucose increased

    creatinine increased

    diarrhea

    rash

    lymphocyte count decreased

    GGT increased

    nausea

    ALT increased

    fatigue

    hemoglobin decreased

    lipase increased

    decreased appetite

    stomatitis

    vomiting

    weight decreased

    calcium decreased

    glucose decreased

    aPTT prolonged

    alopecia

    Mechanism of Action

    Piqray (alpelisib) is an inhibitor of phosphatidylinositol-3-kinase (PI3K) with inhibitory activity predominantly against PI3Kα. Gain-of-function mutations in the gene encoding the catalytic α-subunit of PI3K (PIK3CA) lead to activation of PI3Kα and Akt-signaling, cellular transformation and the generation of tumors in in vitro and in vivo models. 

    In breast cancer cell lines, alpelisib inhibited the phosphorylation of PI3K downstream targets, including Akt and showed activity in cell lines harboring a PIK3CA mutation. In vivo, alpelisib inhibited the PI3K/Akt signaling pathway and reduced tumor growth in xenograft models, including models of breast cancer. P

    I3K inhibition by alpelisib treatment has been shown to induce an increase in estrogen receptor (ER) transcription in breast cancer cells. The combination of alpelisib and fulvestrant demonstrated increased antitumor activity compared to either treatment alone in xenograft models derived from ER-positive, PIK3CA mutated breast cancer cell lines.

    Additional Information

    For additional information regarding Piqray or HR+, HER2-negative, PIK3CA-mutated advanced or metastatic breast cancer, please visit the Piqray web page.

    Approval Date: 2019-05-01
    Company Name: Novartis
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