Regulatory Affairs

FDA grants priority review to Merck’s Keytruda for cervical cancer

PBR Staff Writer Published 14 March 2018

Merck’s anti-PD-1 therapy Keytruda (pembrolizumab) has been granted priority review designation by the US Food and Drug Administration (FDA) for the treatment of advanced cervical cancer.

The company’s supplemental Biologics License Application (sBLA), which has been accepted by the regulator, is seeking approval for treating patients whose cervical cancer had progressed on or after chemotherapy.

The regulator is expected to make a decision on Keytruda’s approval for the new indication by 28 June, 2018.

Merck had filed its application for the new indication partly based on the findings of the ongoing phase 2 KEYNOTE-158 trial.

The global, open-label, non-randomized trial is assessing the effect of Keytruda in patients with various forms of advanced solid tumors including cervical cancer that have advanced on standard of care therapy.

Last year, the US saw nearly 13,000 cases of cervical cancer diagnosed. According to Merck, the five-year survival rate of women with stage IV disease is estimated to be 15-16%.

Merck Research Laboratories oncology late-stage development senior vice president and therapeutic area head Roger Dansey said: “Advanced cervical cancer is an illness with a poor prognosis and a high unmet medical need.

“We look forward to working with the FDA on the review of this application to help bring Keytruda to previously-treated patients with advanced cervical cancer.”

The company is carrying out an extensive clinical development program for Keytruda in a wide range of cancers that affect women. The program has so far included various studies assessing the drug as a monotherapy or in combination with other anti-cancer treatments in multiple forms of breast and gynecological cancers.

Keytruda has been approved either as a single agent or in combination in the US for lung cancer, skin cancer, head and neck cancer, lymphoma among other types of cancer.

The anti-PD-1 therapy functions by boosting the ability of the body’s immune system to help identify and fight tumor cells.

Keytruda is a humanized monoclonal antibody that blocks PD-1 from interacting with its ligands, PD-L1 and PD-L2. As a result, it helps in activating T lymphocytes that can affect tumor cells and also healthy cells.


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