Ferring’s Adstiladrin had been in development since 2011 and, with last year’s approval, is now on track for initial marketing.
The gene therapy treats a high-risk form of the most common type of bladder cancer, known as non-muscle invasive bladder cancer, or NIMBC, that is unresponsive to Bacillus Calmette-Guérin therapy. It uses an adenovirus vector to deliver a gene for the immune-stimulating protein interferon alfa-2b, administered once every three months via a catheter to the bladder.
But common to gene therapies are manufacturing hurdles and viral vector bottlenecks, even after the challenging development process.
