Story at a glance

  • Keytruda was approved for use in combination with chemotherapy for patients with triple-negative breast cancer.
  • The approval follows trial data from more than 1,000 patients.
  • TNBC makes up about 10 to 15 percent of all breast cancers and tends to be more common in younger women and African American women.

A treatment for early-stage, triple-negative breast cancer (TNBC), an aggressive type of cancer with an increased risk of recurrence, has received approval from the Food and Drug Administration (FDA). 

Pharmaceutical company Merck announced Tuesday the health agency gave the nod for its immunotherapy Keytruda to be used in combination with chemotherapy for patients with high-risk, early-stage TNBC. 

The approval follows trial data from more than 1,000 patients. The data show use of the drug in combination with chemotherapy before surgery, and use as a monotherapy post-surgery, helped increase the time a patient is free of certain cancer-related events, including recurrence. 


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“Even when TNBC is diagnosed early, 30-40% of patients will suffer cancer recurrence after standard neoadjuvant chemotherapy and surgery,” Joyce O’Shaughnessy, chair of breast cancer research at Baylor University Medical Center, said in a statement

“Therefore, there is a high unmet need for new treatment options. Today’s approval is very welcome news and has the potential to change the treatment paradigm by now including an immunotherapy as part of the regimen for patients with high-risk early-stage TNBC,” O’Shaughnessy said. 

TNBC makes up about 10 to 15 percent of all breast cancers and tends to be more common in younger women and African American women. The cancer grows and spreads faster than other types of invasive breast cancer and has limited treatment options, resulting in a worse prognosis.


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Published on Jul 28, 2021