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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 see below for full Important Safety Information and click here for full Prescribing Information for PIQRAY® (alpelisib) tablets.

Testing for PIK3CA mutations

Learn key information about PIK3CA mutations, including their prevalence, implications, and how to test for the mutation.


Please see below for full Important Safety Information and click here for full Prescribing Information for PIQRAY® (alpelisib) tablets.

 

Downloadable resources

PIK3CA Mutation CDx Testing Visual Aid

Download the PIK3CA Mutation CDx Testing Visual Aid for more information about when, why, and how to test for PIK3CA mutations

  Download Guide

FAQs

There are 4 ways to order the CDx tests:
Option 1: NeoGenomics PIK3CA Mutation CDx Testing Program utilizing QIAGEN's therascreen® PIK3CA RGQ PCR Kit 
Eligible patients may receive one free PIK3CA mutation testing using an FDA-approved test for purposes of determining whether the patient is eligible for alpelisib for an FDA-approved indication, without regard to purchase of any prescribed drug or any other product. No patient, health care program or beneficiary shall be billed for this mutation test. The test shall not be included in a bundled payment to any healthcare facility including, but not limited to, a hospital. The ordering physician shall not be compensated any fees in connection with this mutation testing, such as for specimen collection, handling, or data reporting. Program is not valid where prohibited by law. Novartis reserves the right to rescind, revoke, or amend the program without notice. 
Option 2: Alternate lab for PIK3CA Mutation CDx Testing using QIAGEN's therascreen® PIK3CA RGQ PCR Kit
NeoGenomics is the only lab currently performing testing under the PIK3CA Mutation CDx Testing Program, and alternate labs will process the test outside of the PIK3CA Mutation CDx Testing Program. For more information, visit the QIAGEN Lab Finder or call NeoGenomics Customer Service at 1-800-755-1605.
Option 3: Verify QIAGEN's therascreen® PIK3CA RGQ PCR Kit in your lab
Order the kit and verify the PIK3CA Mutation CDx test with your lab with QIAGEN. If you have questions, please contact QIAGEN at 1-800-362-7737.
Option 4: Foundation Medicine's FoundationOne®CDx
For more information about ordering the FoundationOne CDx, call Foundation Medicine Client Services at 1-888-988-3639.

  • NeoGenomics Laboratories is implementing the Novartis PIK3CA Mutation CDx Testing Program and will perform the QIAGEN therascreen® PIK3CA RGQ PCR CDx.

    The PIK3CA Mutation Companion Diagnostic (CDx) Testing Program is designed to provide access to PIK3CA mutation testing for appropriate HR+/HER2- advanced breast cancer patients. Appropriate patients may receive one free PIK3CA mutation testing using an FDA-approved test of record for the purpose of determining whether or not the patient has a PIK3CA mutation and is eligible for alpelisib for an FDA-approved indication, without regard to purchase of any prescribed drug or any other product. No patient, health care program, or beneficiary shall be billed for this mutation test.

  • Currently, the PIK3CA Mutation CDx testing program only covers tissue specimens. Please visit this website for future updates.
  • PIK3CA mutation CDx testing includes 11 different mutations in the PIK3CA gene as part of the FDA-approved indication.
  • PIK3CA gene-functional domains

  • Please inquire with the lab you are ordering a PIK3CA Mutation CDx test through.
  • Please inquire with the lab you are ordering a 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.

  • Foundation Medicine generally expects to provide results in less than 2 weeks from specimen receipt. For more information, call Foundation Medicine at 1-888-988-3639.

  • 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.

    For technical information about the Foundation Medicine FoundationOne®CDx, please visit www.foundationmedicine.com/genomic-testing/foundation-one-cdx or call 1-888-988-3639.

  • For the QIAGEN therascreen® PIK3CA RGQ PCR Kit, tumor tissue or plasma derived from peripheral whole blood can be used. For the Foundation Medicine FoundationOne®CDx test, tumor tissue can be used.

    Primary breast tumor tissue or metastatic tissue specimens may be used for testing and you may test archival tissue.

  • When using the QIAGEN therascreen® RGQ PCR kit, QIAGEN expects that decalcified bone metastasis tissue will not be able to be tested using the PIK3CA Mutation Companion Diagnostic as it will produce an invalid result.

    When using the FoundationOne®CDx, Foundation Medicine recommends that you do not decalcify the sample.

    For further questions please contact the lab that you are ordering from.

  • Please inquire with the lab you are ordering a PIK3CA Mutation CDx test from.
  • For more information about specimen requirements, please contact the lab you are ordering a PIK3CA Mutation CDx test from.
  • To verify the QIAGEN therascreen® RGQ PCR Kit in your lab, 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. The incidence of grade 3 and 4 hypersensitivity reactions was 0.7%. 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 in patients treated with PIQRAY. SJS and EM were reported in 0.4% and 1.1% of patients, respectively. Do not initiate PIQRAY treatment in patients with a history of SJS, EM, or toxic epidermal necrolysis (TEN). If signs or symptoms of severe cutaneous reactions occur, interrupt PIQRAY until the etiology of the reaction has been determined. Consultation with a dermatologist is recommended.

If SJS, TEN, or EM is confirmed, permanently discontinue PIQRAY. Do not reintroduce PIQRAY in patients who have experienced previous severe cutaneous reactions during PIQRAY treatment. If it is not confirmed, PIQRAY may require dose modifications, topical corticosteroids, or oral antihistamine treatment.

Advise patients of the signs and symptoms of severe cutaneous reactions (eg, a prodrome of fever, flu-like symptoms, mucosal lesions, or progressive skin rash).

Hyperglycemia: Severe hyperglycemia, including ketoacidosis, has been reported in patients treated with PIQRAY. Hyperglycemia was reported in 65% of patients treated with PIQRAY. Grade 3 (FPG >250-500 mg/dL) and Grade 4 (FPG >500 mg/dL) hyperglycemia was reported in 33% and 3.9% of patients, respectively. Ketoacidosis was reported in 0.7% of patients (n=2) treated with PIQRAY.

Before initiating treatment with PIQRAY, test FPG, HbA1c, and optimize blood glucose. After initiating treatment with PIQRAY, 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. If a patient experiences hyperglycemia after initiating treatment with PIQRAY, monitor blood glucose and/or FPG as clinically indicated, and at least twice weekly until blood glucose or FPG decreases to normal levels. During treatment with antidiabetic medication, continue monitoring blood glucose or FPG at least once a week for 8 weeks, followed by once every 2 weeks and as clinically indicated. Consider consultation with a health care practitioner with expertise in the treatment of hyperglycemia and counsel patients on lifestyle changes.

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 medical history of type 2 diabetes were included. Patients with a history of diabetes mellitus may require intensified diabetic treatment. Closely monitor patients with diabetes.

Based on the severity of the hyperglycemia, PIQRAY may require dose interruption, reduction, or discontinuation. 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. Pneumonitis was reported in 1.8% of patients treated with PIQRAY.

In patients who have new or worsening respiratory symptoms or are suspected to have developed pneumonitis, interrupt PIQRAY immediately and evaluate the patient for pneumonitis. 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.

Permanently discontinue PIQRAY in all patients with confirmed pneumonitis. Advise patients to immediately report new or worsening respiratory symptoms.

Diarrhea: Severe diarrhea, including dehydration and acute kidney injury, occurred in patients treated with PIQRAY. Most patients (58%) experienced diarrhea during treatment with PIQRAY. Grade 3 diarrhea occurred in 7% (n=19) of patients. 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: Based on findings in animals and its mechanism of action, PIQRAY can cause fetal harm when administered to a pregnant woman. Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with PIQRAY and for 1 week after the last dose. Advise male patients with female partners of reproductive potential to use condoms and effective contraception during treatment with PIQRAY and for 1 week after the last dose. Refer to the Full Prescribing Information of fulvestrant for pregnancy and contraception information.

The most common adverse reactions (all grades, incidence ≥20%) were diarrhea (58%), rash (52%), nausea (45%), fatigue (42%), decreased appetite (36%), stomatitis (30%), vomiting (27%), weight decreased (27%), and alopecia (20%). The most common grade 3/4 adverse reactions (incidence ≥2%) were rash (20%), diarrhea (7%), fatigue (5%), weight decreased (3.9%), nausea (2.5%), stomatitis (2.5%), and mucosal inflammation (2.1%).

The most common laboratory abnormalities (all grades, incidence ≥20%) were glucose increased (79%), creatinine increased (67%), lymphocyte count decreased (52%), gamma glutamyl transferase (GGT) increased (52%), alanine aminotransferase (ALT) increased (44%), hemoglobin decreased (42%), lipase increased (42%), calcium decreased (27%), glucose decreased (26%), and activated partial thromboplastin time (aPTT) prolonged (21%). The most common grade 3/4 laboratory abnormalities (incidence ≥5%) were glucose increased (39%), GGT increased (11%), lymphocyte count decreased (8%), and lipase increased (7%), and potassium decreased (6%).

Please click here for full Prescribing Information.

therascreen is a registered trademark of QIAGEN Group.

Foundation Medicine and FoundationOne CDx are registered trademarks of Foundation Medicine, Inc.

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