The FDA has approved Anktiva as the first treatment specifically for adults with BCG-unresponsive, high-grade papillary-only bladder cancer that has not spread into the bladder muscle.
The expanded approval covers Anktiva (nogapendekin alfa inbakicept-pmln) given with Bacillus Calmette-Guérin, according to an Oct. 14 FDA news release. The agency based its decision on evidence supporting an earlier Anktiva approval for adults with carcinoma in situ, with or without papillary tumors, and scientific similarities between the diseases.
The trial supporting the earlier approval evaluated 77 adults. Sixty-two percent achieved a complete response, with 58% of those maintaining the response for at least 12 months and 40% for at least 24 months.
Anktiva is administered with BCG directly into the bladder through a catheter once a week for six weeks. Additional treatment depends on response and may continue for up to 37 months.
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