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FDA Approves Merck’s KEYTRUDA in Combination Therapy for Advanced Cervical Cancer: A Milestone in Treatment Options

NextEdge Admin

23 Dec 2023

2 min 23 sec

Merck , known as MSD outside of the United States and Canada, has received approval from the U.S. Food and Drug Administration (FDA) for its anti-PD-1 therapy, KEYTRUDA, in combination with chemoradiotherapy (CRT) for treating patients with FIGO 2014 Stage III-IVA cervical cancer. The approval is based on positive results from the Phase 3 KEYNOTE-A18 trial, demonstrating that KEYTRUDA plus CRT led to a 41% reduction in the risk of disease progression or death compared to placebo plus CRT. This marks the third indication for KEYTRUDA in cervical cancer and the 39th in the U.S.

Dr. Bradley Monk, an oncologist and professor, highlights the significance of this approval, providing patients with a new anti-PD-1-based treatment option. The regimen offers hope for improved outcomes for those with newly diagnosed FIGO 2014 Stage III-IVA cervical cancer.

KEYTRUDA’s mechanism of action may lead to immune-mediated adverse reactions, emphasizing the importance of early identification and management. The therapy’s approval as the first anti-PD-1-based regimen for FIGO 2014 Stage III-IVA cervical cancer, irrespective of PD-L1 expression, expands treatment options for patients.

Dr. Gursel Aktan, Vice President of Global Clinical Development at Merck Research Laboratories, emphasizes the approval’s significance in providing newly diagnosed patients with an anti-PD-1-based treatment option that may reduce the risk of disease progression or death compared to chemoradiotherapy alone. In the U.S., KEYTRUDA already has two additional approved indications for cervical cancer, further solidifying its role in advanced cervical cancer treatment.