FDA Approves New Therapy for Metastatic Breast Cancer

new breast cancer treatment approved
Harold J. Burstein, MD, PhD

The U.S. Food and Drug Administration has approved a new treatment  for women with advanced (metastatic) breast cancer. The new therapy, palbociclib, will be used to treat postmenopausal women with metastatic estrogen receptor-positive (ER-positive) breast cancer who have not received previous treatment.

Palbociclib, which is marketed under the name Ibrance, will be used in combination with another breast cancer drug, letrozole.

“This is a new class of drugs that has been effective in treating this particular pathway in cancer, and it has improved outcomes for patients with advanced ER-positive breast cancer, one of the most common forms of the disease,” says Harold J. Burstein, MD, PhD, a breast cancer specialist with the Susan F. Smith Center for Women’s Cancers at Dana-Farber.

Palbociclib was tested in a trial of 165 women with ER-positive advanced breast cancer who had not received previous treatment. Patients who were treated with palbociclib and letrozole lived about 20 months without the disease progressing. Women who received just the letrozole lived about 10 months without the disease progressing.

New drug approved for metastatic breast cancer
Sara Tolaney, MD, and Geoffrey Shapiro, MD, help connect breast cancer patients with clinical trials.

The drug’s effectiveness is also being tested in treating early stage breast cancer, Burstein says.

The FDA approved palbociclib under its accelerated approval program, which allows faster approval of a drug if it is used to treat a serious or life-threatening disease and clinical trial data shows it is likely to benefit patients. The approval was based on a small, randomized phase II study and full approval will depend on results of a phase III trial that has not yet reported data.

3 thoughts on “FDA Approves New Therapy for Metastatic Breast Cancer”

  1. Are there plans or a timeline for approval for stage 4 women who have already had treatment? There are so many of us who have been on hormonal therapy already for our metastases, and so many of us who have developed metastases after treatment for ER+ early stage cancer where the standard of care is tamixifen or an AI. Is this breakthrough out of reach for every one of us?

  2. Dear Kathryn —
    Thank you for your question and for reading our Insight blog. We spoke with Dr. Burstein, who told us there are several ongoing studies looking at this class of drug in women who have already had treatment for ER+ breast cancer. I hope this is helpful. Wishing you all the best!

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