BRIEF—First breast cancer indication approved for Keytruda in Europe

Adding another string to the bow of the mega-blockbuster checkpoint inhibitor, the European Commission (EC) has approved Keytruda (pembrolizumab), Merck & Co’s anti-PD-1 therapy, in combination with chemotherapy for the first-line treatment of locally recurrent unresectable or metastatic triple-negative breast cancer (TNBC) in adults whose tumors express PD-L1 (Combined Positive Score [CPS] ≥10) and who have not received prior chemotherapy for metastatic disease.

Triple-negative breast cancer is an aggressive type of breast cancer. This represents the first approval in Europe in a breast cancer setting for Keytruda, which generated first-half sales of over $8 billion.

“This approval is an important milestone for appropriate patients with metastatic TNBC who are in need of new treatment options,” said Dr Javier Cortés, head of the International Breast Cancer Center (IBCC), Quironsalud Group. “With this approval, patients in Europe with metastatic TNBC whose tumors express PD-L1 (CPS ≥10) have a new immunotherapy treatment option that can be used in combination with different chemotherapy agents,” he added.