FDA Approves Gedatolisib for Metastatic HR-Positive Breast Cancer

On July 14, the U.S. Food and Drug Administration (FDA) approved gedatolisib (brand name: Revtorpyk). The medicine is to be used in combination with Faslodex (chemical name: fulvestrant) with or without Ibrance (chemical name: palbociclib) to treat people diagnosed with hormone receptor-positive, HER2-negative locally advanced or metastatic breast cancer without a PIK3CA mutation if the metastatic cancer grew during or after treatment with hormonal therapy.

Locally advanced breast cancer is breast cancer that has spread to tissue near the breast, but not to parts of the body away from 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.

The approval was based on results from the VIKTORIA-1 study, which compared outcomes in people with metastatic hormone receptor-positive, HER2-negative breast cancer who took one of three treatment regimens: a combination of gedatolisib, Faslodex, and Ibrance; a combination of gedatolisib and Faslodex; or Faslodex alone. The primary outcome was progression-free survival — how long people lived without the cancer growing.

Progression-free survival was 9.3 months for people who received gedatolisib, Faslodex, and Ibrance; 7.4 months for people who received gedatolisib and Faslodex; and 2 months for people who received only Faslodex.

See gedatolisib prescribing information.

Gedatolisib is targeted therapy medicine called a PI3K/AKT/mTOR inhibitor. It works differently than currently approved PI3K/AKT/mTOR inhibitors, like Piqray (chemical name: alpelisib). This allows the medicine to treat breast cancer that doesn’t have a PIK3CA mutation.

Gedatolisib is given as an infusion through an IV or a port. The recommended dosage is a 180-mg infusion over 30 minutes on days one, eight, and 15 of each 28-day cycle. You receive gedatolisib along with Faslodex, with or without Ibrance.

Like nearly all breast cancer medicines, gedatolisib can cause side effects. The most common side effects seen in the VIKTORIA-1 trial were:

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  mouth and throat sores

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  low white blood cell counts

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  nausea

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  vomiting

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  rash

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  fatigue

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  diarrhea

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  hyperglycemia (high blood sugar)

Gedatolisib also can harm a fetus. You shouldn’t receive gedatolisib if you’re pregnant, trying to get pregnant, or if there is any chance that you could be pregnant. Anyone who could become pregnant should use an effective non-hormonal type of birth control while receiving gedatolisib and for two weeks after the last dose. Ask your doctor which type of non-hormonal birth control would be best for you.

You also shouldn’t breastfeed while receiving gedatolisib.

If you’re a man receiving gedatolisib and have a partner who can become pregnant, your partner should use birth control while you’re receiving gedatolisib and for two weeks after the last dose.

The cost of gedatolisib may vary. The price you’ll pay depends on your health insurance provider and plan, where you live, and the pharmacy you use. 

Note: Your insurance company may require you to get prior authorization before covering gedatolisib.

Celcuity, the company that makes gedatolisib, has a Support Services Program that may be able to help you with the cost of gedatolisib. Call 877-4-CELCUITY (877-423-5284), Monday-Friday, 8 a.m.-8 p.m. ET.

Learn more about financial assistance and tips for lowering medicine costs.