FDA approves new treatment for specific bladder cancer cases
The U.S. Food and Drug Administration authorized Anktiva for adults suffering from non-muscle invasive bladder cancer that failed BCG therapy.
This marks the first time a drug has received clearance specifically for patients whose disease remains active after failing standard immunotherapy treatment. The decision relied on data from an earlier approval involving a different form of non-muscle invasive bladder cancer.
Non-muscle invasive bladder cancer stays outside the muscle layer and includes flat patches or small finger-like growths on the lining. High-grade types grow faster and spread more easily than low-grade versions found in these specific patient groups.
The FDA found that adding Anktiva gives the immune system a new method to combat the disease when the standard injection alone is insufficient. This strategy helps individuals whose cancer was not controlled by BCG treatment alone previously.
The regulator granted permission to Altor BioScience, LLC after reviewing proof that these cancer types share important biological features. These shared characteristics allowed the agency to apply evidence from CIS studies to support approval for high-grade papillary-only disease now.