August 16, 2019
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Alpelisib (Piqray) is a targeted therapyinfo-icon approved by the U.S. Food and Drug Administrationinfo-icon to treat people with advanced or metastaticinfo-icon, hormone receptorinfo-icon-positive breast cancer that has tested positive for a mutationinfo-icon on the PIK3CA geneinfo-icon. It is a PI3K (phosphatidylinositol-3 kinase) inhibitor,  a type of medicineinfo-icon that works by blocking a pathway in cancer cells, called PI3K, that may cause breast cancers to stop responding to hormonal therapies. It is given with the hormonal therapyinfo-icon fulvestrantinfo-icon (Faslodexinfo-icon).

Alpelisib was approved by the FDAinfo-icon in May 2019 and is the first PI3K inhibitor approved to treat breast cancer. 

How Alpelisib Works

A mutationinfo-icon on the PIK3CA geneinfo-icon can cause the PI3K pathway in breast cancer cells to become too active. Researchers believe this path causes some breast cancer to stop responding to hormonal therapyinfo-icon. Alpelisib is a PI3K inhibitor, meaning it blocks this pathway and works with hormonal therapy to keep the cancer from growing.

Who Gets Alpelisib

Alpelisib is approved for people with advanced or metastaticinfo-icon, hormone receptorinfo-icon-positive, HER2-negative breast cancer that has grown during or after treatment with hormonal therapyinfo-icon. The tumorinfo-icon must also test positive for a mutationinfo-icon on the PIK3CA geneinfo-icon. This mutation is present in the tumors of about 40 percent of people with this diagnosisinfo-icon. Along with alpelisib, the FDAinfo-icon approved a biomarker test, the therascreenPIK3CA RGQ PCR kit, to test for this mutation.

How Alpelisib is given

Alpelisib is a pill. The standard doseinfo-icon is two 150 milligram tablets each day. It is given along with fulvestrantinfo-icon, which is given as a shot. Fulvestrant is given three times the first month, then once a month after that.

Side Effects and Things to Remember

High blood sugar is a notable side effectinfo-icon of alpelisib. In the SOLAR-1 trial it was the most common reason people stopped treatment with alpelisib. It can be managed with diabetes medicines, changes in diet, changes to the doseinfo-icon of alpelisib, and taking a break from alpelisib.

Other common side effects were

Tell your doctor if you are pregnant or planning to become pregnant. Alpelisib may be dangerous to a fetus so it is recommended that you not take this medicineinfo-icon while pregnant and not get pregnant for at least a week after you have stopped treatment.

Alpelisib can also cause some serious but rare conditions including lung inflammationinfo-icon, allergic reactions, and severe skin reactions. Let your doctor know if you have had any serious skin reactions to medicines in the past.

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