- FDA expanded the approved use of Anktiva, given with BCG, to adults with high-grade papillary-only bladder cancer that has not spread into the bladder muscle and has not responded to BCG.
- The approval is the first FDA-approved treatment specifically for BCG-unresponsive, high-grade papillary-only disease.
- FDA based the decision on Anktiva's earlier approval for carcinoma in situ (CIS) and on shared clinical and laboratory features between CIS and high-grade papillary-only disease.
- The supporting CIS trial (NCT03022825) enrolled 77 adults; 62% achieved a complete response, and of those, 58% maintained it for at least 12 months and 40% for at least 24 months.
- FDA is working toward finalizing draft guidance that would discuss using CIS study evidence to support approval of treatments for BCG-unresponsive, high-grade papillary-only NMIBC.
- The approval was granted to Altor BioScience, LLC.
Quotes
“We listen to patients, clinicians, and researchers, and we act when the science supports a new approach”
“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.”