FDA Expands Anktiva Immunotherapy Approval for BCG-Unresponsive Bladder Cancer
The agency said evidence from 77 patients supported the broader use after 62% achieved a complete response in the earlier trial.
- The FDA expanded approval of Anktiva, making it the first treatment specifically authorized for BCG-unresponsive, high-grade papillary-only disease.
- Previously authorized for BCG-unresponsive NMIBC with CIS, the agency based this expansion on existing efficacy Evidence showing similar disease characteristics and recurrence risk.
- Data from the QUILT-3 trial of 77 Patients showed 62% achieved a complete response, with 58% maintaining that response for 12 months or more.
- R. Angelo de Claro, MD, director of the FDA Oncology Center of Excellence, said the agency acts "when the science supports a new approach" to treating BCG-unresponsive disease.
- While Anktiva provides a new option, the FDA warns that delaying cystectomy can lead to metastatic bladder cancer; Patients receive Maintenance therapy for up to 37 months.
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14 Articles
FDA expands Anktiva immunotherapy approval for BCG-unresponsive bladder cancer
The FDA expanded the approval of a first-in-class immunotherapy to include a new subgroup of people with bladder cancer.Nogapendekin alfa inbakicept-pmln (Anktiva, Altor BioScience LLC/ImmunityBio) is now indicated for use with Bacillus Calmette-Guérin (BCG) for adults with high-grade papillary-only bladder cancer that has not spread into the bladder muscle and hasnot responded to prior BCG
FDA Expands ANKTIVA® Approval for BCG-Unresponsive Non-Muscle-Invasive ...
ImmunityBio (IBRX) Stock: Climbs as FDA Expands ANKTIVA Approval for Bladder Cancer
TLDR IBRX climbs 1.12% to $9.91 as FDA expands ANKTIVA’s bladder cancer approval. FDA clears ANKTIVA plus BCG for papillary-only bladder cancer patients in the U.S. ANKTIVA’s wider label opens treatment to more patients with BCG-resistant tumors. Clinical trial finds 62% complete response rate among 77 bladder cancer patients. ImmunityBio sees a larger U.S. market [...]
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