The Food and Drug Administration (FDA) approved Merck’s immunotherapy Keytruda for early treatment of triple-negative breast cancer (TNBC) in combination with chemotherapy, the pharmaceutical company announced on Tuesday.
The federal agency’s endorsement to use Keytruda along with chemotherapy marks the first time a treatment involving an immunotherapy was approved for patients with early stage TNBC, which has a higher recurrence rate.
The FDA confirmed its approval of Keytruda to The Hill.
Merck’s immunotherapy, which helps the immune system find and combat tumor cells, is now approved to treat 30 types of cancer in the U.S.
The approval followed a trial involving more than 1,100 patients with early-stage TNBC, in which the drug was used with chemotherapy before surgery and as a monotherapy following surgery. The trial results indicated the treatment regimen could help lengthen the amount of time a patient is free of certain cancer-related events, including recurrence.
Joyce O’Shaughnessy, the chair of breast cancer research at Baylor University Medical Center, said that even with early diagnosis, 30 to 40 percent of TNBC patients endure recurrence following chemotherapy and surgery.
“Therefore, there is a high unmet need for new treatment options,” she said. “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.”
About 10 percent to 15 percent of breast cancer patients receive a TNBC diagnosis. It is most commonly diagnosed in those younger than 40 years old and among African Americans.
—Updated at 12:45 p.m.