FDA expands Anktiva approval for bladder cancer
The FDA expanded the approval of a first-in-class immunotherapy to include a new subgroup of people with bladder cancer.
Nogapendekin alfa inbakicept-pmln (Anktiva, Altor BioScience LLC/ImmunityBio) is now indicated for use with Bacillus Calmette-Guérin (BCG) for adults with high-grade papillary-only bladder cancer that has not spread into the bladder muscle and hasnot responded to prior BCG treatment. It is the first therapy approved specifically for this setting.
The agent — an interleukin-15 receptor agonist administered into the bladder through a catheter — was previously approved for use