Cancer Education and Research Institute (CERI)'s Cancer Education Programs 

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Breast Cancer Treatments 

Aygün Sahin, MSc, PhD  | CEO and Cancer Lead, Cancer Education and Research Institute (CERI)
This page will be updated regularly!

FDA approved treatments for Breast Cancer

FDA approvals in 2021 
  • July 26, 2021: The FDA approved pembrolizumab for high-risk early-stage triple-negative breast cancer
​The Food and Drug Administration (FDA) approved pembrolizumab (Keytruda, Merck) for high-risk, early-stage, triple-negative breast cancer (TNBC) in combination with chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery.

The FDA also granted regular approval to pembrolizumab in combination with chemotherapy for patients with locally recurrent unresectable or metastatic TNBC whose tumors express PD-L1 as determined by an FDA approved test.
FDA granted accelerated approval to pembrolizumab for this indication in November 2020.

The results of each of the clinical trials are as follow:

Pathological complete response (pCR) rate:
Patients who received pembrolizumab in combination with chemotherapy:  63% (95% CI: 59.5, 66.4)
Patients who received chemotherapy alone: 56% (95% CI: 50.6, 60.6)

Event free survival (EFS):
Patients who received pembrolizumab in combination with chemotherapy:  123% (16% CI: 59.5, 66.4)
Patients who received chemotherapy alone: 93% (24% CI: 50.6, 60.6)
HR 0.63; 95% CI: 0.48, 0.82; p=0.00031
FDA approvals in 2020 
  • December 16, 2020: FDA approved MARGENZA for treatment of metastatic HER2-positive breast cancer
​The Food and Drug Administration (FDA) approved MARGENZA (injection) for adult patients with previously treated metastatic HER2-positive breast cancer.
Learn more here.
  • May 20, 2020:  FDA approved diagnostic imaging agent, Cerianna, for estrogen receptor (ER)-positive patients with breast cancer
The Food and Drug Administration (FDA) approved CERIANNA (fluoroestradiol F 18) as a drug for the visual detection of estrogen receptor (ER)-positive lesions in addition to tissue biopsy in patients with recurrent or metastatic breast cancer.
Learn more here.
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Resources: 
  1. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-high-risk-early-stage-triple-negative-breast-cancer?utm_medium=email&utm_source=govdelivery  (accessed on July 27, 2021)
  2. https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshot-margenza (accessed on July 27, 2021)
  3. https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trial-snapshot-cerianna (accessed on July 27, 2021)

Click here to learn everything you need to know about breast cancer and how to do breast self-examination (BSE) on our Youtube channel.

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