On October 14, 2026, the U.S. Food and Drug Administration expanded the approved use of Anktiva for bladder cancer to include certain adults whose disease has not responded to Bacillus Calmette-Guérin, or BCG. The approval covers high-grade papillary-only cancer that has not grown into the bladder muscle. Anktiva, also called nogapendekin alfa inbakicept-pmln, is given with BCG—not as a replacement for it.
According to the FDA’s approval announcement, Anktiva is the first FDA-approved treatment specifically for people with BCG-unresponsive, high-grade papillary-only disease. The decision expands an earlier approval for a related form of bladder cancer.
Who the expanded approval of Anktiva for bladder cancer covers
The new indication applies to adults with a particular type of non-muscle invasive bladder cancer, or NMIBC. This means the cancer has not grown into the bladder’s muscle layer. “Papillary-only” describes tumors that grow from the bladder lining as small, finger-like projections, without carcinoma in situ, or CIS.
CIS forms flat patches along the bladder lining and is always high-grade. Papillary tumors can be either low-grade or high-grade. High-grade cancers are more likely to grow and spread than low-grade cancers.
BCG activates the immune system inside the bladder to fight cancer and is often an initial treatment for high-risk NMIBC. But cancer can persist or return. Adding Anktiva gives the immune system another way to fight the cancer and can help some people whose disease was not controlled by BCG alone.
What evidence supported the decision?
The FDA used evidence from Anktiva’s earlier approval for adults with BCG-unresponsive CIS, with or without papillary tumors. That approval was supported by a trial, NCT03022825, that evaluated effectiveness in 77 adults.
In that study, 62% achieved a complete response, meaning no high-grade cancer was detected during follow-up assessments. Among those who achieved a complete response, 58% maintained it for at least 12 months and 40% for at least 24 months.
These results came from people with CIS, some of whom also had papillary tumors. They should not be read as response rates measured specifically in the newly approved papillary-only population.
For the expanded approval, the FDA considered those results alongside clinical and laboratory evidence showing important similarities between CIS and high-grade papillary tumors. The cancers often occur together, can be difficult to distinguish under a microscope, and carry a high risk of returning or progressing when BCG no longer works.
The agency said this approach may also help guide future treatment development. It is working toward finalizing draft guidance discussing how evidence from CIS studies may support approvals for BCG-unresponsive, high-grade papillary-only NMIBC.
How treatment is given and why monitoring matters
Anktiva and BCG are delivered directly into the bladder through a catheter. The FDA describes an initial course of once-weekly treatment for six weeks, with additional treatment based on the cancer’s response. Treatment may continue for up to 37 months.
The announcement states that treatment should stop if cancer persists after a second six-week course, returns or progresses, or side effects become unacceptable. These decisions require assessment by the treating medical team.
Side effects and the warning about delaying surgery
The most common side effects and laboratory abnormalities included painful, frequent or urgent urination; blood in the urine; urinary tract infections; muscle or joint pain; chills; fever; and increased blood levels of creatinine and potassium.
Anktiva’s prescribing information also warns that delaying surgery to remove all or part of the bladder can allow cancer to spread elsewhere in the body, which can be fatal. This warning is important when discussing treatment choices and assessing whether treatment is working.
Frequently Asked Questions
Does this approval cover all bladder cancers?
No. The expanded indication specifically covers adults with BCG-unresponsive, high-grade papillary-only bladder cancer that has not invaded the bladder muscle.
Is Anktiva used instead of BCG?
No. Under this approval, Anktiva is given together with BCG, directly into the bladder.
What should patients discuss with their cancer care team?
Relevant topics include whether their cancer matches the approved indication, how response will be assessed, possible side effects, and the risks of delaying bladder-removal surgery.
