FDA Approves First Treatment for Certain People With BCG-Unresponsive Bladder Cancer

The U.S. Food and Drug Administration today expanded the approved use of Anktiva (nogapendekin alfa inbakicept-pmln), given with Bacillus Calmette-Guérin (BCG), to include adults with high-grade papillary-only bladder cancer that has not spread into the bladder muscle and has not responded to BCG treatment. Anktiva is the first FDA-approved treatment specifically for patients with BCG-unresponsive, high-grade papillary-only disease.

The approval marks a new FDA approach to evaluating treatments for BCG-unresponsive non-muscle invasive bladder cancer (NMIBC). The agency based its decision on evidence supporting an earlier approval of Anktiva for adults with another form of NMIBC, carcinoma in situ (CIS), with or without papillary tumors, and scientific similarities between CIS and high-grade papillary-only disease.

“We listen to patients, clinicians, and researchers, and we act when the science supports a new approach,” said R. Angelo de Claro, M.D., Director of the FDA’s Oncology Center of Excellence . “For Anktiva, our review of the similarities between these cancers allowed us to build on the results in patients with CIS and expand treatment options for people with high-grade papillary tumors alone. This approach may also help guide the development of future treatments.”

NMIBC is bladder cancer that has not grown into the bladder’s muscle layer and can include CIS and papillary tumors. CIS forms flat patches along the bladder’s lining, while papillary tumors grow from the lining into the bladder as small, finger-like projections. CIS is always high-grade, while papillary tumors can be low-grade or high-grade. High-grade cancers are more likely to grow and spread than low-grade cancers.

Treatment for high-risk NMIBC often starts with BCG, which activates the immune system inside the bladder to fight cancer. Sometimes, however, the cancer persists or returns. Adding Anktiva gives the immune system another way to fight the cancer, and the combination can help some people whose cancer was not controlled by BCG alone.