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First PI3K Inhibitor Approved for Breast Cancer

Last week, the U.S. FDA (United States Food and Drug Administration) approved the first PI3K inhibitor for advanced or metastatic breast cancer. Specifically, the drug Piqray (alpelisib) is for individuals with HR-positive, HER2-negative breast cancer (hormone receptor-positive, human epidermal growth factor receptor 2-negative), that also has a PIK3CA mutation. Piqray is intended to be used alongside a hormone-based treatment regimen called fulvestrant and is for individuals whose cancer has progressed during or after hormone therapy on its own. Piqray is indicated for use in post-menopausal women, and men.

Determine if Pigray is right for you

A doctor or healthcare provider can help determine whether an individual’s breast cancer is HR-positive and HER2-negative. In order to find out if an individual’s cancer cells have the PIK3CA mutation, a special kit called the therascreen PIK3CA RGQ PCR Kit has been approved by the FDA for use before an individual starts treatment with Piqray. Individuals whose cancer cells do not test positively for the mutation using the kit may need a second test called a tumor biopsy to make sure that they are still not a candidate for the new treatment option.

What is Piqray?

Piqray is the first PI3K inhibitor approved for the treatment of advanced breast cancer. PI3K inhibitors aim to block pathways involved in the growth and development of cells, including cancerous cells. The drug was approved under the Real-Time Oncology Review pilot program, which allows promising medications to make it through the drug approval process in a speedier manner. Piqray is made by Novartis and is an example of how treatments are becoming more and more specific in order to target certain cancers on a more individualized basis. It’s accompanying diagnostic kit is made by Qiagen Manchester, Ltd.

Piqray clinical trial information

The approval of Piqray was based on the results of the SOAR-1 clinical trial, which included over 570 men and postmenopausal women with HR-positive, HER2-negative advanced or metastatic breast cancer. All participants’ cancers had progressed during or after treatment with an aromatase inhibitor (a type of hormonal therapy). Overall, the trial found that those taking Piqray and fulvestrant together, who also had a PIK3CA mutation, had a prolonged progression-free survival than those without the mutation. On average those with the mutation who took Piqray and fulvestrant had progression-free survival of 11 months versus 5.7 months for those without the mutation. This result showed that Piqray is a promising treatment option for those with this specific cell profile and mutation.

Side effects of Piqray

The most common side effects of Piqray were found to be hyperglycemia (high blood sugar), diarrhea, low red and white blood cell counts, nausea, fatigue, elevated liver, pancreas, and kidney function tests, upset stomach, rash, vomiting, low calcium levels, and weight loss. Additionally, some individuals experienced prolonged blood clotting time. Piqray may lead to severe skin reactions, like rashes or blistering of the skin, lips, or gums. Individuals with a past history of severe skin reactions may not be able to take Piqray. Since Piqray may impact an individual’s blood sugar, those taking Piqray should have their HbA1c monitored (a measure of blood sugar). Those taking Piqray should also be monitored for inflammation of the lungs, allergic reactions, and diarrhea.

  1. FDA Approves First PI3K Inhibitor for Breast Cancer. U.S. Food and Drug Administration. https://www.fda.gov/news-events/press-announcements/fda-approves-first-pi3k-inhibitor-breast-cancer. Published May 24, 2019. Accessed May 26, 2019.

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