The U.S
FDA has accepted an application for a supplemental biologics license (sBLA) for the anti-PD-1 therapy Keytruda and granted priority review, The company announced
The sBLA application approved Keytruda as a single therapy for the treatment of specific high-risk non-muscular leachate bladder cancer (NMIBC) patients, specifically:
do not qualify for bladder removal or have chosen not to have bladder removal of the card seed no response, high risk, insitually in situ cancer (CIS), accompanied by or not accompanied by nipple-like lesions of NMIBC patients
FDA's Advisory Board on Oncology and Drugs will meet on December 17 to discuss the sBLA
Mercadon expects the FDA to make a final review decision in January 2020 based on priority reviews
the results of this new indication application based on open label, multi-cocination Phase II clinical study KEYNOTE-057 (NCT02625961)
The study was conducted in high-risk NMIBC patients who did not respond to the current standard therapy, which did not respond to or did not meet or refuse to undergo a curative cystomy, and was divided into two groups of 260 patients: patients with CIS or CIS-plus papillomastography (queue A, n-130), papillomatric lesions and patients without CIS (queue B, n-130)
Both groups were treated with Keytruda (a fixed dose of 200 mg intravenously every three weeks) until the disease returned, disease progression, unacceptable toxicity, or was treated in patients without progression of the disease until 24 months
interim analysis data from Group A were presented at the 2018 ESMO Annual Meeting, showing that the total remission (CR) rate was 38.8% (95% CI: 29.4-48.9; n?103) at the 3-month duration of Keytruda treatment
According to the Kaplan-Meier method, 80% of patients who reached CR at 3 months had CR lasting 6 months or more, and the median remission duration in CR patients had not reached (0 plus to 14.1 plus) at 14.0 months
In this study, Keytruda's safety was consistent with previous studies of single-drug therapy
bladder cancer begins with the uncontrolled growth of cells in the bladder, and as more cancer cells appear, they can form tumors and spread to other parts of the body
Bladder cancer is described according to the extent to which it invades the bladder wall, and NMIBC occurs when the cancer cells do not grow to the main muscle layer of the bladder
It is estimated that more than 80,000 new cases of bladder cancer will be diagnosed in the United States in 2019, and about 75 percent of bladder cancer patients will be diagnosed with NMIBC
For high-risk NMIBC patients with no response to the cacao, persistent or recurrent disease, the treatment guidelines recommend a curative cystomy, a surgical procedure to remove the entire bladder, which usually requires the removal of other surrounding organs
high-risk NMIBC treatment options have traditionally been limited, and many patients rely on surgery after the disease recurs
In addition, about 40% of high-risk NMIBC patients progress to muscle-soaked disease
THE KEYNOTE-057 STUDY SHOWED THAT
KEYTRUDA SINGLE-DRUG TREATMENT ACHIEVED A FULL REMISSION RATE OF
, WHICH IS VERY ENCOURAGING FOR PATIENTS AT HIGH RISK OF INCURABLE RISK OF BLADDER REMOVAL WHO ARE NOT ELIGIBLE OR REFUSED TO ACCEPT BLADDER REMOVAL
Keytruda is an anti-PD-1 therapy that helps detect and fight tumor cells by improving the body's immune system
Mercadon has the largest clinical research program for immuno-oncology in the industry
More than 1,000 clinical trials are currently being studied in a variety of cancer and treatment settings to understand keytruda's role in cancer treatment and to predict what patients can benefit from Keytruda treatment
In June, Moshadon held its first investor day meeting in five years and said it expected Keytruda to more than double its approval of treatments over the next five years
Reference source: FDA Grants Priority Review to Merck's Supplemental BiologyS License Application (sBLA) for KEYTRUDA ® (Pembrolizumab) in Certain Patients with High-Risk, Non--Muscle Muscle Cancer (NMIBC)
