The FDA has approved Merck's Keytruda for early treatment of triple-negative breast cancer in combination with chemotherapy, the drugmaker said July 27.
The approval marks the first time a treatment involving an immunotherapy was approved for patients with early stage triple-negative breast cancer, Merck said. Keytruda helps the immune system find and combat tumor cells.
Keytruda is now approved to treat 30 types of cancer in the U.S.
The approval of the drug to treat triple-negative breast cancer was based on a clinical trial of 1,174 patients with early stage disease. The trial results indicated the drug could help lengthen the amount of time a patient is cancer free.
Even with early diagnosis, 30 percent to 40 percent of patients with triple-negative breast cancer experience recurrence after chemotherapy and surgery, Joyce O'Shaughnessy, MD, the chair of breast cancer research at Baylor University Medical Center in Dallas, told The Hill.
"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," she said.
Roughly 10 percent to 15 percent of breast cancer patients are diagnosed with triple-negative breast cancer, The Hill reported. It's most commonly found in those younger than 40 and in African Americans.
Read Merck's full news release here.