What to Know About Revtorpyk for Breast Cancer

Written by Patricia Weiser, PharmD
Medically Reviewed by Rachel Maynard, PharmD on August 24, 2026

If you have advanced breast cancer, your health care provider may recommend a medicine called Revtorpyk (gedatolisib) as part of your treatment plan.

Revtorpyk is used for certain people with hormone receptor-positive (HR-positive), HER2-negative breast cancer. These types of breast cancer use hormones or other signals to help them grow. Revtorpyk blocks a group of signals inside cancer cells that can help drive cancer growth.

Below are frequently asked questions and answers about Revtorpyk for advanced breast cancer.

Revtorpyk is not right for everyone. To help decide if Revtorpyk is an option for you, your health care provider will consider the type of breast cancer you have, how much it has spread, and which treatments you have already tried.

Revtorpyk may be used after certain other treatments have stopped working. Revtorpyk is FDA-approved for adults with breast cancer that meet all of the following requirements:

  • The cancer is HR-positive and HER2-negative.
  • The cancer is advanced, meaning it has spread into nearby tissue or lymph nodes, or metastatic, meaning it has spread to other parts of the body.
  • The cancer has gotten worse during or after at least one hormone therapy used for metastatic breast cancer.
  • Testing has not found a PIK3CA mutation in the cancer.

The PIK3CA gene is involved in signals that help cells grow. Some breast cancers have mutations, or abnormal changes, in this gene. Before you start Revtorpyk, your health care provider may test your cancer for PIK3CA mutations. Revtorpyk is an option when these mutations are not detected.

Revtorpyk is used with one or more other medicines:

Fulvestrant. Revtorpyk is typically used with another breast cancer medicine called fulvestrant. Fulvestrant is a type of hormone therapy. It’s usually given as monthly injections into your gluteal (butt) muscles. It blocks the estrogen hormone from attaching to receptors on breast cancer cells and also helps break down these receptors. This can slow the growth of cancer cells that depend on estrogen.

Palbociclib. In some cases, your health care provider may also add palbociclib. Palbociclib is a targeted medicine. It’s usually taken by mouth once daily on a three-weeks-on, one-week-off schedule. It blocks certain proteins that help control how cells grow and divide. Blocking these proteins can help slow the growth of cancer cells.

If you have not yet gone through menopause, your treatment plan may also include a hormone therapy called a gonadotropin-releasing hormone (GnRH) agonist. These medicines lower the amount of hormones made in your body. In the main clinical trial of Revtorpyk, all premenopausal and perimenopausal women received a GnRH agonist.

Your health care provider will prescribe the combination that best fits your needs.

Revtorpyk is a type of targeted cancer medicine called a kinase inhibitor. It blocks several proteins that are part of a cell-signaling system called the PI3K/AKT/mTOR pathway.

This pathway helps control how cells grow, divide, and survive. In HR-positive breast cancer, the pathway can become an important source of growth signals. It can also help cancer cells keep growing after hormone therapy or medicines called CDK4/6 inhibitors stop working as well.

Revtorpyk blocks all four main forms of PI3K as well as two mTOR protein complexes. Blocking these proteins shuts down many growth signals at once. This can slow the growth of breast cancer cells and cause cancer cells to die.

Fulvestrant works in a different way by blocking estrogen signaling. Palbociclib, when used, blocks another pathway that helps cancer cells divide. Using these medicines together allows treatment to target more than one way that breast cancer cells may grow.

Revtorpyk does not cure advanced breast cancer, but it may help slow the cancer from getting worse.

Revtorpyk is given through a vein as an IV infusion. A health care provider will give you each infusion over about 30 minutes.

Treatment with Revtorpyk typically follows a 28-day cycle:

  • You receive Revtorpyk once a week for the first three weeks, on days 1, 8, and 15.
  • You do not receive Revtorpyk during the fourth week.
  • The cycle then starts again.

The recommended dose for each infusion is 180 milligrams (mg). Treatment usually continues as long as it helps control your cancer and the side effects are manageable. Your health care provider may pause treatment or lower your dose if you have certain side effects.

If you miss a Revtorpyk infusion, contact your health care provider to reschedule it as soon as you can.

Your health care provider will also give you an alcohol-free mouthwash that contains a steroid when you start Revtorpyk. This is used to help prevent mouth sores, which are a common side effect of the medicine. Read this article to learn more about Revtorpyk side effects.

Revtorpyk was studied in a clinical trial called VIKTORIA-1. The FDA approved the medicine based on a part of the study that included 392 adults with HR-positive, HER2-negative advanced or metastatic breast cancer without a detected PIK3CA mutation.

Everyone in the study had breast cancer that had gotten worse during or after treatment with certain types of cancer medicines. People could have received up to two previous hormone treatments for advanced or metastatic breast cancer. The study did not include people who had already received medicines that block PI3K, AKT, or mTOR.

Here are some details about the 392 adults who took part in the study:

  • The median age was 56 years, meaning about half of the participants were younger and half were older.
  • Nearly all participants were women.
  • About 70% were White, 16% were Asian, and 2% were Black or African American; race was unknown for 7%.
  • About 65% were not Hispanic or Latino and 28% were Hispanic or Latino; ethnicity was not reported or was unknown for 7%.
  • Everyone had breast cancer that had spread. About 79% had cancer that had spread to organs such as the liver or lungs.

During the study, people were randomly placed into one of three groups:

  1. Revtorpyk plus fulvestrant and palbociclib
  2. Revtorpyk plus fulvestrant
  3. Fulvestrant alone

All women who had not yet gone through menopause also received a GnRH agonist.

People continued their assigned treatment until their cancer got worse or side effects became too severe. People in the fulvestrant-only group could switch to one of the Revtorpyk combinations if their cancer got worse.

The main goal of the study was to measure progression-free survival. This is the amount of time people lived without their cancer getting worse. An independent group of experts reviewed body scans to check whether the cancer had progressed.

The study also looked at how many people’s tumors shrank or disappeared on scans and how long those responses lasted.

Both Revtorpyk treatment combinations helped people live longer without their cancer getting worse compared with fulvestrant alone.

For people who received Revtorpyk, fulvestrant, and palbociclib:

  • The median progression-free survival was 9.3 months, compared with two months for people who received fulvestrant alone.
  • Among people whose tumors could be measured, about 32% had their tumors shrink or disappear on scans, compared with 1% of people who received fulvestrant alone.
  • Among those who responded to treatment, the response lasted a median of 17.5 months.

In this context, median means the middle point when looking at everyone’s results from shortest to longest.

For people who received Revtorpyk and fulvestrant:

  • The median progression-free survival was 7.4 months, compared with two months for people who received fulvestrant alone.
  • Among people whose tumors could be measured, about 28% had their tumors shrink or disappear on scans.
  • Among those who responded to treatment, the response lasted a median of 12 months.

At the time these results were analyzed, researchers did not yet have enough information to know whether Revtorpyk helped people live longer overall.

Your results may be different from what was seen in the study.

Revtorpyk starts working in your body soon after your first dose, but if and how long it takes to see a response to treatment can vary from person to person. In the VIKTORIA-1 clinical trial, participants had body scans to check their tumors every eight weeks during the first year of treatment.

This means it may take many weeks or months before your health care provider can tell from scans how well treatment is working. Your response may be faster or slower than someone else’s. Your health care provider will monitor your cancer during treatment and let you know how well Revtorpyk is working for you.

Patient support programs are available for Revtorpyk from the drugmaker to help with access and treatment costs. Services include help navigating insurance coverage, a copay savings program, and a patient assistance program. Eligibility requirements apply. Visit this website or call 877-423-5284 to learn more about financial support options for Revtorpyk.

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