FDA Approves Revtorpyk for Advanced HR-Positive, HER2-Negative Breast Cancer

The Food and Drug Administration (FDA) has approved Revtorpyk (gedatolisib) in combination with fulvestrant, with or without Ibrance (palbociclib), for adults with hormone receptor (HR)-positive, HER2-negative locally advanced or metastatic breast cancer that does not have a PIK3CA mutation. The approval is for patients whose cancer has grown or spread after treatment with at least one hormone (endocrine) therapy for metastatic disease.

What This Approval Means for Patients

HR-positive, HER2-negative breast cancer is the most common type of breast cancer. Many people respond well to hormone therapy at first, but over time the cancer can stop responding to treatment and begin growing again.

Revtorpyk is a targeted therapy that blocks signals cancer cells use to grow and survive. When used with fulvestrant, with or without Ibrance, it gives patients another treatment option after hormone therapy is no longer working.

This approval is only for patients whose tumors do not have a PIK3CA mutation. Your doctor can determine this through biomarker testing, which looks for specific genetic changes in the tumor.

What the Clinical Trial Found

The FDA based its approval on the phase 3 VIKTORIA-1 clinical trial, which included 392 adults with locally advanced or metastatic HR-positive, HER2-negative breast cancer.

Researchers compared three treatment groups:

• Revtorpyk plus fulvestrant and Ibrance
• Revtorpyk plus fulvestrant
• Fulvestrant alone

The main goal was to see how long patients lived before their cancer got worse, a measure called progression-free survival.

Patients who received Revtorpyk with fulvestrant and Ibrance lived a median of 9.3 months without their cancer progressing, compared with 2 months for patients who received fulvestrant alone.

Patients who received Revtorpyk with fulvestrant also benefited, going a median of 7.4 months before their cancer worsened.

The treatment also shrank tumors in more patients. Among those with measurable tumors:

• 32% of patients receiving Revtorpyk, fulvestrant and Ibrance saw their tumors shrink.
• 28% of patients receiving Revtorpyk and fulvestrant had their tumors shrink.
• Only 1% of patients receiving fulvestrant alone experienced tumor shrinkage.

At the time of the analysis, researchers were still collecting information on whether the treatment helps patients live longer overall.

How Revtorpyk Is Given

Revtorpyk is given through an intravenous (IV) infusion that takes about 30 minutes. Patients receive the treatment once a week on Days 1, 8 and 15 of every 28-day cycle.

It is given together with fulvestrant, with or without Ibrance, and treatment continues until the cancer grows or side effects become too severe.

Possible Side Effects

The prescribing information for Revtorpyk includes warnings about:

• Mouth sores (stomatitis)
• Skin reactions
• High blood sugar (hyperglycemia)
• Possible harm to an unborn baby during pregnancy

Patients should talk with their oncology team about the benefits and risks of treatment, as well as how side effects will be monitored and managed.

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