Approvals

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 haematopoietic 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 US 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.”

Dr Bradley Monk, oncologist and professor of obstetrics and gynecology at University of Arizona’s College of Medicine and Creighton University School of Medicine, both US, added: “Today’s approval of Keytruda plus chemoradiotherapy is welcome news and gives patients with newly diagnosed FIGO 2014 Stage III-IVA cervical cancer, for the first time ever, the option of an anti-PD-1-based regimen to treat their cancer. This Keytruda-based regimen offers a new treatment option for these patients, so today’s approval has important implications for the way we treat them moving forward.”