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News
The FDA has expanded approval of Anktiva (nogapendekin alfa inbakicept-pmln) to cover adults with high-grade papillary-only bladder cancer that hasn't responded to BCG treatment — making it the first therapy approved for this specific setting. The interleukin-15 receptor agonist is administered directly into the bladder alongside BCG. This expansion builds on Anktiva's existing approval for BCG-unresponsive nonmuscle-invasive bladder cancer with carcinoma in situ.
The FDA has expanded the approval of Anktiva (nogapendekin alfa inbakicept-pmln), a first-in-class immunotherapy, to now include adults with high-grade papillary-only bladder cancer that hasn't spread into the bladder muscle and hasn't responded to prior BCG treatment. This marks the first therapy ever approved specifically for this patient subgroup — a meaningful milestone for those who've run out of options after standard BCG therapy stops working.
Anktiva, an interleukin-15 receptor agonist made by Altor BioScience LLC/ImmunityBio, is delivered directly into the bladder via catheter, once weekly for six weeks. The FDA's decision was informed by existing evidence in carcinoma in situ patients and the recognized similarities between that condition and high-grade papillary-only disease — including a shared high risk of recurrence or progression when BCG alone fails.
Key Takeaways:
Why it matters: BCG failure in bladder cancer has long left clinicians with limited options. This expanded approval gives oncologists and urologists a validated, targeted tool for a previously underserved patient population, potentially reducing disease progression and improving outcomes.
