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FDA Approves Piqray to Treat Advanced-Stage Hormone-Receptor-Positive, HER2-Negative Breast Cancer With PIK3CA Mutation

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On May 24, 2019, the U.S. Food and Drug Administration (FDA) approved Piqray (chemical name: alpelisib) in combination with Faslodex (chemical name: fulvestrant) to treat metastatic and advanced-stage, hormone-receptor-positive, HER2-negative breast cancer with a PIK3CA mutation that has grown after hormonal therapy treatment in postmenopausal women and men.

Read the FDA announcement.

Advanced-stage breast cancer is breast cancer that has spread to tissue near the breast. Metastatic breast cancer is breast cancer that has spread to parts of the body away from the breast, such as the bones or liver. Metastatic breast cancer is considered advanced-stage disease.

About Piqray

Piqray is a targeted therapy medicine that inhibits the PI3K pathway. The PI3K pathway helps all cells — both healthy and cancer cells — get the energy they need. When this pathway is overactivated because of a mutation in the PIK3CA gene, it can allow cancer cells to survive and grow. PI3K inhibitors block this pathway, with the goal of killing cancer cells.

Piqray is a pill taken by mouth.

Different mutations in the PIK3CA gene make different forms of the PI3 protein, called isoforms by researchers. There are several isoforms of PI3; one of them is the alpha isoform. Piqray specifically targets the alpha isoform.

The FDA approval of Piqray was based on results from the SOLAR-1 trial, which found that Piqray combined with the hormonal therapy Faslodex nearly doubled progression-free survival compared to Faslodex alone (11 months vs 5.7 months) in postmenopausal women and men diagnosed with advanced-stage, hormone-receptor-positive, HER2-negative breast cancer with a PIK3CA mutation.

Progression-free survival is how long a person lives without the cancer growing.

“Piqray is the first PI3K inhibitor to demonstrate a clinically meaningful benefit in treating patients with this type of breast cancer. The ability to target treatment to a patient’s specific genetic mutation or biomarker is becoming increasingly common in cancer treatment,” Richard Pazdur, M.D., director of the FDA’s Oncology Center of Excellence, said in a statement.

Piqray side effects

The most common side effects of Piqray are:

  • high blood sugar levels
  • high creatinine levels, which can mean kidney problems
  • diarrhea
  • rash
  • nausea
  • fatigue
  • low white blood cell counts
  • mouth sores
  • vomiting
  • hair loss
  • loss of appetite

Piqray also may cause serious side effects, including:

  • Severe skin reactions: In some people, Piqray may cause Stevens-Johnson syndrome or erythema multiforme, skin disorders that may begin with flu-like symptoms followed by a painful rash that blisters. If you have a history of either of these two conditions or other skin disorders, discuss them with your doctor before you start treatment with Piqray.
  • High blood sugar: The safety of Piqray has not been established in people diagnosed with Type 1 or uncontrolled Type 2 diabetes. If you have diabetes, your doctor will measure your fasting blood sugar levels and will monitor these levels while you’re being treated with Piqray. If you have symptoms of untreated high blood sugar, including frequent urination, blurred vision, or an increase in thirst, tell your doctor immediately.
  • Pneumonia: Piqray may make some people more likely to develop pneumonia or other upper respiratory infections. Tell your doctor right away if you have chest pain when you breathe or cough, or if you have a fever or chills.
  • Diarrhea: While moderate diarrhea is a common side effect of Piqray, the medicine also can cause severe diarrhea, which can lead to dehydration and may cause kidney problems. Your doctor will recommend an antidiarrheal medicine while you’re being treated with Piqray. If you have diarrhea, tell your doctor immediately.

What this means for you

If you’re a postmenopausal woman or man who has been diagnosed with advanced-stage or metastatic hormone-receptor-positive, HER2-negative breast cancer with a PIK3CA mutation that has grown after hormonal therapy treatment, you and your doctor will consider a number of treatment options, now including Piqray.

Together, you will weigh the benefits and risks of each treatment and decide on the best treatment plan for your unique situation.

Written by: Jamie DePolo, senior editor

Reviewed by: Brian Wojciechowski, M.D., medical adviser

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