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FDA Expands ANKTIVA® Approval for BCG-Unresponsive Non-Muscle-Invasive Bladder Cancer to Cover Both Papillary and CIS Disease

ImmunityBio (IBRX)ImmunityBioFDA / regulatory

Expanded indication extends ANKTIVA plus BCG to patients with BCG-unresponsive non-muscle-invasive bladder cancer (NMIBC), including those with carcinoma in situ (CIS), with or without papillary tumors, and those with papillary-only tumors Papillary disease represents approximately 85% of the NMIBC

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ImmunityBio

Immune-Based Cancer Therapies ImmunityBio develops therapies that activate innate and adaptive immune responses against cancer. Its platform combines cytokine biology, cell therapy and immunotherapy combinations. ANKTIVA ANKTIVA is an IL-15 superagonist approved with BCG for selected patients with BCG-unresponsive non-muscle-invasive...

Recent company news

IBRXImmunityBio2026-11-04 13:00 EST

ImmunityBio Announces First Patients in Europe Treated with ANKTIVA® Plus BCG for BCG-unresponsive Non-Muscle Invasive Bladder Cancer with Carcinoma in Situ

IBRXImmunityBio2026-10-21 11:30 EST

ImmunityBio Announces Database Lock for Registrational Trial of Locally Delivered, Chemotherapy-Free ANKTIVA® Plus BCG in BCG-Naïve Non-Muscle Invasive Bladder Cancer

IBRXImmunityBio2026-10-16 15:49 EST

ImmunityBio Reports Phase 3 Data Showing 84% Cystectomy Avoidance at Three Years and Complete Responses Beyond 53 Months with ANKTIVA® Plus BCG in BCG-Unresponsive NMIBC With CIS, With or Without Papillary Tumors

IBRXImmunityBio2026-10-14 20:18 EST

FDA Expands ANKTIVA® Approval for BCG-Unresponsive Non-Muscle-Invasive Bladder Cancer to Cover Both Papillary and CIS Disease

IBRXImmunityBio2026-10-08 12:30 EST

ImmunityBio to Participate in the Piper Sandler Virtual Oncology Symposium

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7.57B USD
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