ImmunityBio bladder cancer therapy accepted for FDA review to expand label
ImmunityBio (NASDAQ:IBRX) said the U.S. Food and Drug Administration accepted its supplemental Biologics License Application for review, aiming to expand the approved use of its immunotherapy drug Anktiva to treat a wider patient base with non-muscle invasive bladder cancer (NMIBC).
The Culver City, California-based company is seeking clearance to use Anktiva in combination with Bacillus Calmette-Guerin (BCG) for patients with BCG-unresponsive NMIBC who present with papillary disease without carcinoma in situ (CIS).
The FDA assigned a Prescription Drug User Fee Act (PDUFA) target action date of January 6, 2027, according to a company statement.
Anktiva is currently approved to treat BCG-unresponsive NMIBC with CIS, with or without papillary tumors.
Approval of the supplemental application would clear the drug for a significantly larger subset of patients, as approximately 85% of the 64,000 individuals diagnosed with NMIBC in the U.S. each year present with papillary disease.
The FDA’s filing communication indicated that the review was accepted based on additional scientific data requested by the regulator.
The submission detailed overlapping features between papillary and CIS conditions to justify extending the therapeutic indication.
The regulatory milestone aligns with evolving expert consensus on the biology of the disease.
At an FDA workshop held on May 18, 2026, panelists noted that CIS and papillary disease originate from the same cancer-inducing clone, meaning they are biologically the same disease.
Clinicians at the workshop remarked that when papillary disease alone is identified, the standard real-world practice is to treat the patient off-label using FDA-approved therapies indicated for CIS.
The findings match recent clinical practice updates.
In March 2026, the National Comprehensive Cancer Network (NCCN) panel of experts established the treatment of BCG-unresponsive NMIBC papillary disease as a Category 2A guideline for practicing urologists managing patients with papillary disease alone.