FDA expands bladder cancer drug Anktiva to a new group of patients
The FDA expanded its approval of the bladder cancer drug Anktiva to patients with a type of tumor that grows from the bladder lining. It is the first treatment approved for this group. The agency based the decision on earlier results in a related cancer, not a new trial.
The U.S. Food and Drug Administration has expanded its approval of the bladder cancer drug Anktiva to a new group of patients, Healio and Medscape reported Wednesday.
Anktiva, made by ImmunityBio, is given together with BCG, a standard treatment that uses the immune system to fight cancer inside the bladder, both outlets said. The drug is put directly into the bladder through a thin tube.
The new approval covers adults with high-grade "papillary-only" bladder cancer that has not spread into the bladder muscle and has not responded to BCG, Healio reported. Papillary tumors grow from the bladder's lining like small fingers. Anktiva is the first therapy approved specifically for this group, Healio said.
The drug was first approved in 2024 for patients with another form of the disease, called carcinoma in situ, which forms flat patches on the bladder lining, Medscape reported.
The FDA did not require a new trial in papillary-only patients, both outlets said. Instead, it used the earlier results and evidence that the two cancers are closely related. The agency called this a new approach, Medscape said.
In the earlier trial of 77 patients, 62% had a complete response, meaning no high-grade cancer was found during follow-up, Medscape reported. Of those, 58% stayed cancer-free for at least 12 months and 40% for at least 24 months.
"We listen to patients, clinicians and researchers, and we act when the science supports a new approach," said Dr. R. Angelo de Claro, director of the FDA's Oncology Center of Excellence, according to Healio. He said the approach "may also help guide the development of future treatments."
Common side effects include painful or frequent urination, blood in the urine, urinary tract infections, chills and fever, both outlets reported. The drug's label warns that delaying surgery to remove the bladder can let the cancer spread, Medscape said.
What we know: Anktiva is now approved for BCG-unresponsive papillary-only tumors.
What we don't: How well it works in this group, since no separate trial was done.
Where outlets agree Healio and Medscape both report that the FDA expanded Anktiva to high-grade papillary-only disease based on earlier results in carcinoma in situ.
Where they differ The outlets cited here report the same key facts so far.