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Ibrance Approved to Treat Men With Advanced-Stage Hormone-Receptor-Positive Breast Cancer

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On April 4, 2019, the U.S. Food and Drug Administration (FDA) expanded the use of Ibrance (chemical name: palbociclib) so the medicine can now be used to treat men diagnosed with advanced-stage or metastatic hormone-receptor-positive, HER2-negative breast cancer.

Read the FDA announcement.

Advanced-stage breast cancer is breast cancer that has spread to tissue near 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. Metastatic breast cancer is considered advanced-stage disease.

The approval to treat men with Ibrance was based on information submitted by Pfizer, the company that makes Ibrance, showing that the risks and benefits of using Ibrance to treat men were the same as when Ibrance is used to treat women.

“Today we are expanding the indication for Ibrance to include male patients based upon data from postmarketing reports and electronic health records showing that the safety profile for men treated with Ibrance is consistent with the safety profile in women treated with Ibrance,” said Richard Pazdur, M.D., director of the FDA’s Oncology Center of Excellence, in a statement.

About Ibrance

Ibrance is approved to treat women and men diagnosed with advanced-stage or metastatic hormone-receptor-positive, HER2-negative breast cancer in combination with:

  • an aromatase inhibitor as the first hormonal therapy treatment
  • Faslodex (chemical name: fulvestrant) if the cancer has grown after being treated with hormonal therapy

Ibrance is a cyclin-dependent kinase (CDK) 4/6 inhibitor. A kinase is a type of protein in the body that helps control cell division. Ibrance works by stopping cancer cells from dividing and growing.

All the aromatase inhibitors and Ibrance are pills taken by mouth. Faslodex is liquid that is given once a month as an injection into a muscle, usually at your doctor's office.

“Men with breast cancer have limited treatment options, making access to medicines such as Ibrance critically important,” said Bret Miller, founder of the Male Breast Cancer Coalition, in a statement. “We applaud the use of real-world data, a new approach to drug review, to make Ibrance available to certain men with metastatic breast cancer and help address an unmet need for these patients.”

Ibrance side effects

The most common side effects of Ibrance are:

  • infection
  • low white blood cell counts
  • anemia (low red blood cell count)
  • fatigue
  • nausea
  • neuropathy
  • mouth sores
  • hair thinning or loss
  • diarrhea
  • vomiting
  • weakness
  • decreased appetite

Ibrance also may cause serious side effects, including:

Neutropenia (low white blood cell count): Low white blood cell counts are a common side effect of Ibrance. Still, some people’s white blood cell counts may drop so low that they have to decrease the dose of Ibrance or stop treatment. Your doctor will check your white blood cell count before and during treatment with Ibrance.

Infections: Ibrance may make some people more likely to develop infections such as pneumonia or other upper respiratory infections. Tell your doctor right away if you have a temperature higher than 100.5 degrees F, chills, or don’t feel well.

Blood clots: Ibrance may cause serious or life-threatening blood clots in your arteries or lungs. Tell your doctor right away if you have shortness of breath, rapid heart rate, rapid breathing, or a sudden sharp chest pain.

Because Ibrance is given with an aromatase inhibitor or Faslodex, you also may have side effects from those medicines. Common side effects of aromatase inhibitors are bone thinning and bone and joint pain. Common side effects of Faslodex are hot flashes and nausea.

What this means for you

If you’re a man who has been diagnosed with advanced-stage or metastatic hormone-receptor-positive, HER2-negative breast cancer, you and your doctor will consider a number of treatment options, now including Ibrance. Together, you will weigh the benefits and risks of each and decide on the best treatment plan for your unique situation.

To discuss Ibrance with other men diagnosed with breast cancer, join the Discussion Board forum Male Breast Cancer.

Written by: Jamie DePolo, senior editor

Reviewed by: Brian Wojciechowski, M.D., medical adviser

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