FDA approves Merck’s Keytruda with chemoradiotherapy as cervical cancer treatment
Betsy Goodfellow | January 15, 2024 | News story | Medical Communications | FDA, Oncology, cervical cancer, keytruda
Merck, known as MSD outside of the US and Canada, has announced that the US Food and Drug Administration (FDA) has approved Keytruda (pembrolizumab) in combination with chemoradiotherapy (CRT) for the treatment of FIGO (International Federation of Gynecology and Obstetrics) 2014 Stage III-IVA cervical cancer.
The approval follows data from the phase 3 KEYNOTE-A18 trial, in which the drug with CRT demonstrated an improvement in progression-free survival (PFS), and reduced the risk of disease progression or death by 41% compared to placebo plus CRT.
This is the third approval for Keytruda in cervical cancer treatment and the 39th indication for the drug overall in the US.
Immune-mediated adverse reactions from the drug can include pneumonitis, colitis, hepatitis, endocrinopathies, nephritis, dermatologic reactions, solid organ transplant rejection and complications of allogeneic hematopoietic stem cell transplantation.
Dr Gursel Aktan, vice president of global clinical development at Merck Research Laboratories, commented: “Building on the established role of KEYTRUDA in advanced cervical cancer, KEYTRUDA plus chemoradiotherapy is now the first anti-PD-1-based regimen approved in the U.S. for the treatment of patients with FIGO 2014 Stage III-IVA cervical cancer regardless of PD-L1 expression. This approval provides newly diagnosed patients with an anti-PD-1-based treatment option that has the potential to reduce the risk of disease progression or death compared to chemoradiotherapy alone.”
Betsy Goodfellow
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