FDA expands ANKTIVA approval to cover all BCG-unresponsive bladder cancer patients
The expanded label adds patients with papillary-only tumors, a group left out of the drug's April 2024 approval
Published
ImmunityBio said the Food and Drug Administration has widened the approved use of ANKTIVA, given with BCG, to adult patients with BCG-unresponsive non-muscle-invasive bladder cancer whose tumors are papillary-only.
The drug was first approved in April 2024 for BCG-unresponsive patients with carcinoma in situ, with or without papillary tumors. The company said this is the first FDA approval to cover papillary-only disease in this setting, and that ANKTIVA plus BCG is now available to all patients with BCG-unresponsive non-muscle-invasive bladder cancer.
The change extends ANKTIVA's reach to the entire BCG-unresponsive population rather than the carcinoma-in-situ subset it has covered since 2024, closing a gap that had left papillary-only patients without an approved combination option. It follows a pattern seen elsewhere in oncology this fall, including Tecentriq's expansion into adjuvant colon cancer on October 9, where a wider label rather than new clinical data is what moves the drug forward. Because this is an extension of an already-approved treatment, the commercial effect will depend on how many papillary-only patients were not already being treated with ANKTIVA, a number the announcement does not give.