ImmunityBio Inc. (NASDAQ:IBRX) shares are trading higher Thursday after the FDA expanded the approved indication for its bladder cancer immunotherapy ANKTIVA to include BCG-unresponsive non-muscle-invasive bladder cancer with papillary-only tumors.
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FDA Expands ANKTIVA to Papillary-Only Disease, Which Is the Majority of Patients
The updated label covers ANKTIVA in combination with BCG for adults with BCG-unresponsive non-muscle-invasive bladder cancer, or NMIBC. It is the first FDA approval to include patients with papillary-only tumors. It builds on the April 2024 approval for patients with carcinoma in situ, or CIS, with or without papillary tumors. Papillary disease accounts for about 85% of NMIBC patients, and NMIBC makes up about 80% of U.S. bladder cancer diagnoses. ImmunityBio said the expansion significantly increases ANKTIVA’s U.S. addressable patient population and makes it the first FDA-approved therapy for both CIS and papillary-only disease in this setting.
“The expansion of ANKTIVA plus BCG into papillary-only disease broadens the eligible patient population,” said Richard Adcock, President and CEO of ImmunityBio.
The Approval Extrapolates From CIS Data and Not a New Papillary Trial
The approval rests on the FDA’s review of available scientific information, including efficacy ANKTIVA plus BCG previously showed in patients with CIS. In Cohort A of the QUILT-3.032 trial, 62% of 77 patients achieved a complete response. Among those who responded, 58% maintained the response for at least 12 months and 40% for at least 24 months. The FDA said, according to Fierce Pharma, that because CIS and high-grade papillary disease share clinical and non-clinical features, efficacy in CIS could be extrapolated to patients with high-grade papillary disease. It also said it is finalizing draft guidance on developing drugs for BCG-unresponsive NMIBC. Fierce described the road to this approval as bumpy, noting an earlier refusal-to-file.
ImmunityBio Shares Edge Higher
IBRX Price Action: At the time of publication, ImmunityBio shares are trading 3.23% higher at $10.23, according to data from Benzinga Pro.
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