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Picking Up PIK3CA: The importance of detecting a PIK3CA mutation in patients with HR+/HER2- advanced or metastatic breast cancer


Please click here for full Prescribing Information for PIQRAY® (alpelisib) tablets.

FAQs

  • NeoGenomics Laboratories will perform the QIAGEN therascreen® PIK3CA RGQ PCR tissue CDx as part of the PIK3CA Mutation CDx Testing Program. To see what other US labs are able to perform the QIAGEN therascreen® PIK3CA RGQ PCR CDx, please visit QIAGEN.com/PIK3CA-Lab-Finder.
  • Currently, the PIK3CA Mutation CDx testing program only covers tissue specimens. Although a plasma test is FDA-approved, it has not yet been verified by any US laboratory.
  • The FDA-approved PIK3CA Mutation CDx is manufactured by QIAGEN. For more information, please contact QIAGEN at 1-800-362-7737.
  • QIAGEN therascreen® PIK3CA RGQ PCR CDx is the official name of the CDx, and it runs on the QIAGEN therascreen® Rotor-Gene Q platform.
  • The test is intended to aid clinicians in identifying breast cancer patients who have a PIK3CA mutation. The CDx identifies a specific subset of PIK3CA mutations.  
  • Exon
    Mutation
    7
    9
    20
    C420R
    E542K
    E545A
    E545D [1635G>T only]
    E545G
    E545K
    Q546E
    Q546R
    H1047L
    H1047R
    H1047Y
  • Please inquire with the lab you are ordering the PIK3CA Mutation CDx test through.
  • Please inquire with the lab you are ordering the PIK3CA Mutation CDx test through or the appropriate insurance provider.
  • If ordering through NeoGenomics Laboratories, NeoGenomics Laboratories generally expects to provide results within 1 week of specimen receipt by NeoGenomics Laboratories in Carlsbad, CA. For more information, please call NeoGenomics Laboratories at 1-800-755-1605.

    If ordering through a lab other than NeoGenomics, please inquire with the lab you are ordering the PIK3CA Mutation CDx from.

  • The QIAGEN therascreen® PIK3CA RGQ PCR Kit will run on the QIAGEN therascreen® Rotor Gene Q platform. If you have technical questions, please contact QIAGEN customer service at 1-800-362-7737.
  • Tumor tissue or plasma derived from peripheral whole blood is required. Although the plasma PIK3CA Mutation CDx has been commercially available since FDA approval, it has not yet been verified by any US laboratory.

    You may test archival tissue. Primary breast tumor tissue or metastatic tissue specimens may be used for testing. QIAGEN expects that decalcified bone metastasis tissue will not be able to be tested using the PIK3CA Mutation companion diagnostic (will produce an invalid result).

  • Please inquire with the lab you are ordering the PIK3CA Mutation CDx from.
  • For more information about specimen requirements, please contact the lab you are ordering the PIK3CA Mutation CDx from.
  • Call QIAGEN customer service at 1-800-362-7737.

Indication

PIQRAY® (alpelisib) tablets is 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, PIK3CA-mutated, advanced or metastatic breast cancer as detected by an FDA-approved test following progression on or after an endocrine-based regimen.

Important Safety Information
PIQRAY is contraindicated in patients with severe hypersensitivity to it or any of its components.

Severe Hypersensitivity: Severe hypersensitivity reactions, including anaphylaxis and anaphylactic shock, were reported in patients treated with PIQRAY. Severe hypersensitivity reactions were manifested by symptoms including, but not limited to, dyspnea, flushing, rash, fever, or tachycardia. Advise patients of the signs and symptoms of severe hypersensitivity reactions. Permanently discontinue PIQRAY in the event of severe hypersensitivity.

Severe Cutaneous Reactions: Severe cutaneous reactions, including Stevens-Johnson syndrome (SJS) and erythema multiforme (EM) were reported. Do not initiate PIQRAY treatment in patients with a history of SJS, EM, or toxic epidermal necrolysis (TEN). Interrupt PIQRAY if signs or symptoms of severe cutaneous reactions are present (eg, a prodrome of fever, flu-like symptoms, mucosal lesions or progressive skin rash), until etiology of the reaction has been determined. Advise patients of the signs and symptoms of severe cutaneous reactions. Consider consultation with a dermatologist. Permanently discontinue PIQRAY if SJS, EM, or TEN is confirmed.

Hyperglycemia: Severe hyperglycemia, including ketoacidosis, was reported. Before initiating treatment with PIQRAY, test fasting plasma glucose (FPG), HbA1c, and optimize blood glucose. After initiating treatment, monitor blood glucose and/or FPG at least once every week for the first 2 weeks, then at least once every 4 weeks, and as clinically indicated. Monitor HbA1c every 3 months and as clinically indicated. Initiate or optimize antihyperglycemic medications as clinically indicated. Interrupt, reduce dose, or discontinue PIQRAY if severe hyperglycemia occurs. The safety of PIQRAY in patients with type 1 and uncontrolled type 2 diabetes has not been established as these patients were excluded from the SOLAR-1 trial. Patients with a history of diabetes mellitus may require intensified diabetic treatment. Closely monitor patients with diabetes.

Advise patients of the signs and symptoms of hyperglycemia (eg, excessive thirst, urinating more often than usual or higher amount of urine than usual, or increased appetite with weight loss).

Pneumonitis: Severe pneumonitis, including acute interstitial pneumonitis and interstitial lung disease, has been reported in patients treated with PIQRAY. Monitor for clinical symptoms or radiological changes. Consider a diagnosis of non-infectious pneumonitis in patients presenting with non-specific respiratory signs and symptoms such as hypoxia, cough, dyspnea, or interstitial infiltrates on radiologic exams and in whom infectious, neoplastic, and other causes have been excluded by means of appropriate investigations. Interrupt or discontinue PIQRAY if severe pneumonitis occurs. Advise patients to immediately report new or worsening respiratory symptoms.  

Diarrhea: Severe cases of diarrhea, including dehydration and acute kidney injury, have been reported. Based on the severity of the diarrhea, PIQRAY may require dose interruption, reduction, or discontinuation. Advise patients to start antidiarrheal treatment, increase oral fluids, and notify their health care provider if diarrhea occurs while taking PIQRAY.

Embryo-Fetal Toxicity: PIQRAY and fulvestrant can cause fetal harm. Advise patients of potential risk to a fetus and to use effective contraception. Also, refer to Full Prescribing Information of fulvestrant for pregnancy and contraception information.

Most common adverse reactions, including laboratory abnormalities (all grades, incidence ≥20%) were glucose increased (79%), creatinine increased (67%), diarrhea (58%), rash (52%), lymphocyte count decreased (52%), gamma glutamyl transferase increased (52%), nausea (45%), alanine aminotransferase increased (44%), fatigue (42%), hemoglobin decreased (42%), lipase increased (42%), decreased appetite (36%), stomatitis (30%), vomiting (27%), weight decreased (27%), calcium decreased (27%), glucose decreased (26%), activated partial thromboplastin time  prolonged (21%), and alopecia (20%).

Please click here for full Prescribing Information.

9/19 PIQ-1214142