The U.S. Food and Drug Administration has granted priority review designation to MCNA for the treatment of patients with high-risk non-muscle-invasive bladder cancer who are refractory to or relapsing after front-line therapy with a therapeutic alternative to surgery.
The drug, marketed by Telesta Therapeutics and derived from the cell wall fractionation of a non-pathogenic bacteria, is suspected to work through a dual mechanism of immune stimulation and direct anti-cancer effects, according to a news release from the company.
MCNA's efficacy and safety for MCNA were shown in a Phase III trial of 129 patients with non-muscle invasive bladder cancer at high risk for disease recurrence and progression after not responding to treatment with bacillus Calmette-Guérin, who received treatment with 8 mg of MCNA weekly for six weeks followed by three weekly instillations at months 3, 6, 12, 18, and 24.
One year after starting the treatment, 25 percent of the patients were disease-free; and at two years, 19 percent were disease-free, according to the study published in the Journal of Urology (2015;193:1135-1143).
In patients with papillary-only tumors, the disease-free survival rates were 35.1 and 32.2 percent at one and two years, respectively. The median duration of disease-free survival was 32.7 months. And the progression-free survival rates were 87.3, 79.8, and 77.7 percent at one, two, and three years, respectively.
The most common adverse reactions to MCNA for the patients in the study (reported by at least five percent of the study participants) were dysuria, hematuria, increased urinary frequency, urinary urgency, fatigue, and urinary tract infection.
The most frequently reported serious adverse events by patients in the study receiving MCNA were hematuria, syncope, sepsis, and chronic pulmonary disease. Two patients on the trial had serious adverse events that were drug-related, including a severe urinary tract infection and hematuria of moderate severity.
The FDA's priority review designation shortens the time to complete a drug's review and aims to deliver a decision on marketing approval designation for drugs that may offer major advances in treatment or provide a treatment where no adequate therapy exists within six months under the Prescription Drug User Fee Act (PDUFA). The FDA action date for MCNA for this indication is February 27.