On January 8, local time, the U.S. FDA announced the approval of Mercato's PD-1 inhibitor Keytruda (pembrolizumab) as a single drug therapy for specific high-risk non-muscle-immersed bladder cancer (NMIBC) patients, specifically: non-qualified bladder removal or have chosen not to have a bladder removal of the catonic seedlings without response, high risk, associated with insituated cancer (CIS), companion or non-cosmic nipple lesions.
, Keytruda's Supplemental Biologics Licensing Application (sBLA) for patients at high risk NMIBC has been granted priority review by the FDA, and in mid-December 2019, the FDA Advisory Committee on Oncology Drugs (ODAC) voted 9:4 to approve it.
approval also makes Keytruda the first PD-(L) 1 treatment that can be used to treat NMIBC.
approval is based on the results of a multi-center single-arm phase II clinical KEYNOTE-057 study.
the study recruited 148 high-risk NMIBC patients, 96 of whom carried CIS that did not respond to BCG and were associated with or with nipple-like lesions.
patients receive 200 mg of fixed dose of Keytruda every 3 weeks until the disease recurs, progression, unacceptable toxicity, or treatment in patients withnosic progression until 24 months.
results showed that the above 96 high-risk NMIBC patients received Keytruda at 3 months of full remission rate of 41% (95% CI: 31,51), median remission time of 16.2 months, full remission time of more than 12 months of patients accounted for 46%.
one year later, 46 percent of the initial responders remained remission, accounting for 19 percent of all patients in the efficacy analysis, below the 30 percent recommended by the international bladder cancer group.
cyst sydacell begins with 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 by the extent to which it invades the bladder wall, NMIBC occurs when cancer cells do not grow into the main muscle layer of the bladder.
estimates that more than 80,000 new confirmed cases of bladder cancer will be reported in the United States in 2019, with about 75 percent of bladder cancer patients diagnosed with NMIBC.
for high-risk NMIBC patients with a persistent or recurrent disease with caythalysis, treatment guidelines recommend a root-and-treaty bladder removal, an operation to remove the entire bladder that usually requires the removal of other surrounding organs and tissues.
high-risk NMIBC treatment options have traditionally been limited, many patients after the recurrence of the disease can only rely on surgical treatment.
in addition, about 40% of high-risk NMIBC patients develop muscle-immersion disease.
the Keytruda single drug treatment in the KEYNOTE-057 study achieved a total remission rate of over 40%, which is very encouraging for patients with incurable high-risk NMIBC who are not eligible for or refused to undergo bladder removal.
Keytruda, a heavyweight drug in Mersadon, has been approved for treatment of more than 20 indications.
currently, more than 1,000 clinical trials are studying Keytruda in a variety of cancer and treatment settings to understand Keytruda's role in cancer treatment and the factors that predict patients will benefit from Keytruda treatment.
in June, Mr. Mercadon told an investor-day meeting that keytruda was expected to more than double the number of treatments approved over the next five years.
Reference source: FDA approves pembrolizumab for BCG-un, high-risk non-muscle-muscle snob. cancer.