The FDA granted a priority review for a new supplemental Biologics License Application to Keytruda plus concurrent chemoradiotherapy for patients with locally advanced cervical cancer.
The Food and Drug Administration (FDA) accepted a priority review for a new supplemental Biologics License Application to Keytruda (pembrolizumab) plus external beam radiotherapy (EBRT) and concurrent chemotherapy (cisplatin) followed by brachytherapy — a regimen known as concurrent chemoradiotherapy — for the treatment of patients with newly diagnosed high-risk locally advanced cervical cancer, according to Merck, the manufacturer of Keytruda.
Priority reviews are granted to therapies that show promise in improving the outcomes of a serious disease or condition. By granting one, the FDA agrees to work with the developers of the drug to speed up the review of the treatment and have a decision date within six months.
The FDA plans to make their approval decision for this regimen by Jan. 20, 2024.
“The standard of care for patients with locally advanced cervical cancer has not changed in more than two decades, and the majority of patients will experience recurrence or progression of their disease,” Gursel Aktan, vice president, global clinical development, Merck Research Laboratories, said in a press release.
The FDA granted the priority review based on findings from the phase 3 KEYNOTE-A18 clinical trial (also known in Europe as ENGOT-cx11/GOG-3047) that showed that Keytruda plus concurrent chemoradiotherapy led to superior progression-free survival (time from treatment until death or disease worsening) compared to concurrent chemoradiotherapy alone in patients with high-risk locally advanced cervical cancer.
KEYNORE-A18/ENGOT-cx11/GOG-3047 includes approximately 980 patients who were randomly assigned to the Keytruda-containing regimen or placebo plus concurrent chemoradiotherapy. While the main goals of the study were progression-free survival and overall survival (time from treatment until death of any cause), the researchers are also evaluating complete response rate (percentage of patients whose cancer disappears after treatment), objective response rate (percentage of patients whose cancer shrinks or disappears), change in quality of life, number of patients who experience one or more side effects and number of patients who stop participating in the trial due to side effects, according to the trial’s listing on clinicaltrials.gov.
Keytruda, which is an immunotherapy agent that works by blocking PD-1, thereby helping the body’s immune system to find and fight the cancer, was initially approved in the cervical cancer space in 2018 to treat PD-L1—positive disease that progressed on or after chemotherapy. Later, in 2021, the drug received FDA approval for use in combination with chemotherapy and with or without Avastin (bevacizumab) for persistent, recurrent or metastatic cervical cancer that expressed the PD-L1 protein.
Regarding the patient population that this priority review is geared toward, the current first line standard of care for locally advanced or metastatic cervical cancer is cisplatin chemotherapy plus radiotherapy — a therapy protocol that has been a mainstay for years.
“If approved, Keytruda will be the first immunotherapy available for patients with newly diagnosed high-risk locally advanced cervical cancer. We are committed to working closely with the FDA to bring Keytruda to these patients who are in need of additional treatment options,” Aktan said.
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