Regulatory Affairs

Merck's Keytruda secures FDA approval for advanced cervical cancer

PBR Staff Writer Published 13 June 2018

The US Food and Drug Administration (FDA) has expanded the approval of Merck's anti-PD-1 therapy Keytruda (pembrolizumab) for the treatment of recurrent or metastatic cervical cancer in patients whose disease had progressed on or after chemotherapy.

The approval has been given for treatment of patients whose tumors express PD-L1 [Combined Positive Score (CPS) ≥1] as determined by an FDA-approved test.

Merck said that the new indication approval was granted under the regulator’s accelerated approval regulations based on tumor response rate and durability of response. Continued approval for the indication will depend on verification and description of clinical benefit in the confirmatory trials, said the German pharma giant.

Keytruda’s latest approval for advanced cervical cancer was based on the positive findings of the phase 2 KEYNOTE-158 trial held in 98 patients with recurrent or metastatic cervical cancer, who were enrolled in a single cohort (Cohort E).

The trial assessed pembrolizumab in patients with various types of advanced solid tumors whose condition had progressed on standard of care therapy.

Merck Research Laboratories senior vice president, global clinical development head and chief medical officer Roy Baynes said: “KEYTRUDA is now the first anti-PD-1 therapy approved for the treatment of advanced cervical cancer, providing an important new second-line option for certain patients with this disease.

“This approval also marks the first indication for KEYTRUDA in a gynecologic cancer and reflects our ongoing commitment to bring forward innovative treatment options across a broad range of cancers, including cancers that disproportionately affect women.”

Keytruda is a humanized monoclonal antibody that functions by enhancing the ability of the body’s immune system to help identify and fight tumor cells.

The anti-PD-1 therapy prevents PD-1 from interacting with its ligands, PD-L1 and PD-L2, thereby helping in the activation of the T lymphocytes that can affect tumor cells and healthy cells.

In the US, Keytruda had been approved either as a single agent or in combination for the treatment of lung cancer, skin cancer, head and neck cancer, lymphoma and other forms of cancer.


Image: Keytruda (pembrolizumab) Injection 100 mg. Photo: courtesy of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.