FDA has approved KEYTRUDA based on data from KEYNOTE-057, a multicentre, open-label, single-arm trial, involving 96 patients
Arial view of Merck headquarters in Darmstadt, Germany (Credit: Merck KGaA.)
Merck has received the US Food and Drug Administration (FDA) approval for KEYTRUDA, an anti-PD-1 therapy for non-muscle invasive bladder cancer (NMIBC).
The US FDA approval indicated KEYTRUDA as monotherapy for Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk NMIBC patients, with carcinoma with or without papillary tumours and who are not eligible for, or who do not wish to undergo cystectomy.
Merck Research Laboratories clinical research vice president Scot Ebbinghaus said: “Today’s approval of KEYTRUDA reinforces our company’s commitment to expanding existing treatment options for certain patients with high-risk, non-muscle invasive bladder cancer.
“As the first anti-PD-1 therapy approved in this setting, KEYTRUDA will be a new clinical option for a patient population that previously had limited FDA-approved therapies available.”
The company said that the regulatory approval of KEYTRUDA was supported by the data from KEYNOTE-057, a multicentre, open-label, single-arm trial, on 96 patients.
Adverse reactions of KEYTRUDA
KEYNOTE-057 trial has evaluated the safety of the drug, in 148 patients with high-risk NMIBC, of whom 96 patients are with BCG-unresponsive CIS with or without papillary tumours.
The study results showed that KEYTRUDA may cause reactions including severe immune-mediated adverse reactions, including pneumonitis, colitis, hepatitis, endocrinopathies, nephritis and renal dysfunction, severe skin reactions, solid organ transplant rejection.
In addition, the drug may cause severe infusion-related reactions, allogeneic hematopoietic stem cell transplantation complications (HSCT), and may cause foetal harm when used by a pregnant woman.
The company has advised to discontinue the use of KEYTRUDA and administer appropriate corticosteroids if required, based on the severity of the adverse reaction.
NYU Langone Health perlmutter cancer centre genitourinary medical oncology director Arjun V Balar said: “High-risk, non-muscle invasive bladder cancer is a serious disease, characterized by frequent recurrences and progression.
“Historically, patients with high-risk, non-muscle invasive bladder cancer with CIS whose cancer is unresponsive to BCG treatment had limited non-surgical treatment options. As a physician who specializes in the management of bladder cancer, it is encouraging to now have a new treatment option for these patients.”