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Anktiva

Anktiva

Drug

Drug Profile

Anktiva (nogapendekin alfa inbakicept-pmln) is an IL-15 receptor agonist immunotherapy administered intravesically with BCG for selected BCG-unresponsive nonmuscle invasive bladder cancer. It is a U.S.-approved prescription drug with initial U.S. approval in 2024. The agent activates NK and T-cell immune responses through IL-15 receptor signaling.

Drug Class: Interleukin-15 (IL-15) receptor agonist
Approval Status: FDA approved; initial U.S. approval in 2024
Mechanism of Action: IL-15 receptor agonism leading to proliferation and activation of NK, CD8+, and memory T cells without Treg proliferation

Brand Names

ANKTIVA

Indications

\BCG-unresponsive nonmuscle invasive bladder cancer with carcinoma in situ (with or without papillary tumors) in adults, in combination with BCG\

Related News

FDA Approvals and Pipeline Expansion Drive Bladder Cancer Therapeutics Market Growth

Jun 23, 2026

The bladder cancer therapeutics market is expanding with recent FDA approvals including INLEXZO for NMIBC and a KEYTRUDA-Padvev combination for MIBC, while the NMIBC market reached approximately USD 3 billion in 2025 across seven major markets. Ferring reported record revenues exceeding €2.5 billion in 2025, driven by Adstiladrin as its second major growth driver. A robust pipeline of emerging therapies is expected to further transform the market through 2036.

New Research Advances Cancer Immunotherapy Through Clinical Data, Resistance Mechanisms, and Microbiome Insights

Jun 21, 2026

New clinical data for ANKTIVA immunotherapy in lung cancer, a study on EBV-driven resistance via ADAR1 RNA editing, and research on microbiome metabolites modulating immunotherapy response were presented at major conferences and in recent publications.

FDA accepts ImmunityBio sBLA for ANKTIVA plus BCG in papillary bladder cancer

May 20, 2026

ImmunityBio said the FDA accepted its sBLA for ANKTIVA plus BCG in BCG-unresponsive non-muscle invasive bladder cancer with papillary disease. The PDUFA date is Jan. 6, 2027.

ImmunityBio Says Saudi FDA Encouraged rBCG Filing and ANKTIVA Expansion Talks

May 17, 2026

ImmunityBio said the Saudi FDA encouraged submission of a regulatory package for recombinant BCG and opened talks on expanding ANKTIVA with checkpoint inhibitors to additional tumor types. The company expects to file the rBCG package within weeks.

ImmunityBio launches ANKTIVA in Saudi Arabia after accelerated lung cancer approval

Apr 25, 2026

ImmunityBio has commercially launched ANKTIVA in Saudi Arabia for approved bladder and metastatic non-small cell lung cancer indications. The launch follows accelerated approval in lung cancer and extends the drug’s commercial rollout in MENA.

Clinical Trial Advances in Cancer Immunotherapy and Targeted Therapies

Apr 02, 2026

Moderna and Merck advance a Phase 2 trial of mRNA cancer vaccine V940 with pembrolizumab and chemotherapy for metastatic squamous NSCLC. In biliary tract cancer, first-line treatment combines chemotherapy with immunotherapy, while targeted therapy resistance prompts liquid biopsy. ImmunityBio tests a chemotherapy-free NK-cell regimen in non-Hodgkin lymphoma.

ImmunityBio's Anktiva Gains NCCN Guideline Inclusion for Bladder Cancer

Mar 30, 2026

The National Comprehensive Cancer Network has updated its bladder cancer guidelines to include ImmunityBio's Anktiva plus BCG for BCG-unresponsive papillary-only disease. The Category 2A recommendation expands treatment options beyond the drug's initial FDA approval for carcinoma in situ. ImmunityBio also announced its pivotal trial is adequately powered and European distribution partnerships to expand global access.

ImmunityBio Reports Fivefold Revenue Surge Driven by Anktiva Sales Growth

Mar 25, 2026

ImmunityBio reported a fivefold revenue increase to $38.29 million, driven by a 750% surge in unit sales of its cancer drug Anktiva. The company is expanding internationally through partnerships in the Middle East and preparing additional FDA submissions for Anktiva's broader use.

ImmunityBio Resubmits ANKTIVA Bladder Cancer Application to FDA, Advances Saudi Approvals

Mar 09, 2026

ImmunityBio resubmitted its supplemental BLA to the FDA for ANKTIVA in papillary bladder cancer after providing additional data. The company also received encouragement from Saudi regulators to submit a recombinant BCG application and expand ANKTIVA approvals.

Immuno-Oncology Market Forecast to Reach $170 Billion by 2032 Amid Pipeline Expansion

Mar 04, 2026

The immuno-oncology market is projected to grow from $65.22 billion in 2025 to $170.19 billion by 2032, driven by checkpoint inhibitors, CAR-T cell therapy, and cancer vaccines, with North America commanding 43% market share.

Related Clinical Trials

NCT ID	Title	Status	Phase
NCT07123727	A Study to Examine Anktiva for the Treatment of COVID-19.	RECRUITING	PHASE2