dm+d

108811008

Lactation Safety Information

No
No published evidence of safety
Serious adverse effects reported in adults
18 September 2020

New Medicines

Muscle invasive bladder cancer (MIBC) - intravesical delivery system with cetrelimab

Information

New formulation
Janssen
Johnson & Johnson

Development and Regulatory status

None
Phase III Clinical Trials
Phase III Clinical Trials

Category

Antimetabolite. Formulated as a non-resorbable gemcitabine-releasing intravesicular drug delivery system, also called GemRIS, that will control the release of gemcitabine into the bladder over a week.
Bladder cancer is the 4th most common cancer in men and the 11th most common in women. The overall incidence in the UK is 11.4 per 100,000 population. At diagnosis, only about 5% of patients have metastatic disease, usually to lymph nodes, lung, liver, bone and central nervous system. Around 30% have involvement of the muscle layer. Around 70% have superficial disease, of which 10% is CIS [1].
Muscle invasive bladder cancer (MIBC) - intravesical delivery system with cetrelimab
Intravesical