ImmunityBio to launch ANKTIVA for bladder, lung cancer
Key Terms
bacillus calmette-guérin (bcg)
medical
Bacillus Calmette-Guérin (BCG) is a live, weakened strain of bacteria used as a vaccine against tuberculosis and as a longstanding immune-stimulating therapy for certain cancers, most commonly bladder cancer. Investors watch BCG because its supply, regulatory approvals, production capacity and clinical trial results can affect sales, treatment availability and healthcare costs—think of it like a widely used, older tool whose availability and regulatory standing can sway demand and company revenues.
non-muscle invasive bladder cancer (nmibc)
medical
Non-muscle invasive bladder cancer (NMIBC) is a form of bladder cancer that is confined to the inner lining of the bladder and has not grown into the deeper muscle layer; think of it as a superficial patch on wallpaper rather than a stain that has soaked through the wall. It matters to investors because NMIBC often requires repeated treatments and monitoring, drives demand for outpatient therapies and diagnostics, and creates a sizable, ongoing market for drugs, devices, and procedures due to high recurrence and long-term care costs.
carcinoma in situ
medical
Carcinoma in situ is an early-stage abnormal growth where cells look cancerous but remain confined to the tissue surface and have not invaded deeper layers or spread to other parts of the body; think of it like graffiti on a wall that hasn’t cracked the plaster beneath. For investors, it matters because treatments, regulatory pathways, clinical trial outcomes and long-term costs differ greatly between contained lesions and invasive cancer, influencing market value, approval odds and liability for healthcare companies.
checkpoint inhibitor
medical
A checkpoint inhibitor is a type of medicine that helps the immune system spot and attack cancer by blocking proteins that act like brakes on immune cells. For investors, these drugs matter because clinical trial results, regulatory approvals, safety profiles and market demand can quickly change a developer’s revenue and valuation; think of them as releasing the brakes on the immune system—potentially high reward but with safety and trial-risk consequences.
metastatic non-small cell lung cancer
medical
A type of lung cancer that starts in the lungs and has spread to other parts of the body; “non-small cell” describes a group of common lung tumor types that behave differently from the rarer small-cell form. It matters to investors because metastatic cases drive demand for long-term treatments, ongoing clinical trials, and regulatory decisions; think of it as a problem that’s moved beyond a single room and now requires more complex, costly solutions with large market and pricing implications.
u.s. food and drug administration
regulatory
The U.S. Food and Drug Administration is the federal agency that evaluates and enforces safety, effectiveness and labeling standards for medicines, medical devices, vaccines, food and related products before they reach consumers. For investors it matters because FDA approvals, warnings or recalls determine whether a product can be sold, how quickly it reaches the market and how costly compliance will be—changes that directly affect a company’s revenue, costs and stock value.
european commission
regulatory
The European Commission is the executive arm of the European Union that proposes and enforces EU laws, manages the EU budget, and represents the bloc in trade and regulatory matters. It matters to investors because its decisions on regulations, competition enforcement, approvals and fines can reshape entire industries, affect company profits and risk, and change where capital flows—much like a referee and rulemaker whose calls influence how the game is played.
saudi food and drug authority (sfda)
regulatory
Saudi Food and Drug Authority (SFDA) is the national regulator that sets and enforces safety and quality rules for food, medicines, medical devices and cosmetics in Saudi Arabia. Its approvals, inspections and rules act like traffic signals for companies — green lights let products be sold and grow revenue, while delays or restrictions can limit market access, affect sales and change a company’s investment risk and value.
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Biopharma & Cigalah are two of the largest pharmaceutical commercial distributors in the
Middle East andNorth Africa (MENA) -
ImmunityBio established a wholly owned subsidiary in the
Kingdom of Saudi Arabia to support physicians and healthcare systems throughout the MENA region - The Registration Certificate of Pharmaceutical Product with pricing has been issued to ImmunityBio from the Saudi FDA
- ANKTIVA will be available for distribution within the next 60 days
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Initiated discussion with Saudi FDA and
UAE regulatory authorities to expand ANKTIVA indications beyond Lung and Bladder cancers
ImmunityBio, Inc. (NASDAQ: IBRX), a commercial-stage immunotherapy company, today announced a partnership with Biopharma and Cigalah, two of the largest and most respected healthcare commercial and distribution companies in the
Under the agreement, Biopharma and Cigalah Healthcare will support the commercialization and distribution of ANKTIVA in two indications: In combination with Bacillus Calmette-Guérin (BCG) for patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) carcinoma in situ, with or without papillary disease; and in combination with a checkpoint inhibitor for patients with metastatic non-small cell lung cancer.
ImmunityBio has established a wholly owned subsidiary in
“We’re pleased to partner with two of the largest healthcare and distribution companies to launch to ANKTIVA to patients in
The MENA region has significant unmet needs for the treatment of serious cancers, which are on the rise in many countries. Lung cancer is among the most prevalent cancers in
“At Cigalah and Biopharma our goal is to ensure that physicians and their patients have ready access to the most advanced therapies available for the most difficult-to-treat diseases like cancer,” said Tamer Eissa, General Manager, Biopharma. “That is exactly what ImmunityBio brings with ANKTIVA, and we are pleased to partner with them to help extend the lives of bladder and lung cancer patients in
“We have just returned from a highly productive trip to the
ANKTIVA received
About ANKTIVA® (nogapendekin alfa inbakicept)
The cytokine interleukin-15 (IL-15) plays a crucial role in the immune system by affecting the development, maintenance, and function of key immune cells—NK and CD8+ killer T cells—that are involved in killing cancer cells. By activating NK cells, ANKTIVA® overcomes the tumor escape phase of clones resistant to T cells and restores memory T cell activity with resultant prolonged duration of complete response. ANKTIVA® is a first-in-class IL-15 agonist IgG1 fusion complex, consisting of an IL-15 mutant (IL-15N72D) fused with an IL-15 receptor alpha, which binds with high affinity to IL-15 receptors on NK, CD4+, and CD8+ T cells. This fusion complex of ANKTIVA® mimics the natural biological properties of the membrane-bound IL-15 receptor alpha, delivering IL-15 by dendritic cells and driving the activation and proliferation of NK cells with the generation of memory killer T cells that have retained immune memory against these tumor clones.
Saudi Arabia Indication and Usage
BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) carcinoma in situ:
ANKTIVA in combination with Bacillus Calmette-Guérin (BCG) is indicated for the treatment of adult patients with high-risk BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) of carcinoma in situ (CIS) with or without papillary disease.
Non-small cell lung cancer (NSCLC):
ANKTIVA is indicated in combination with immune checkpoint inhibitors for the treatment of adult patients with metastatic NSCLC with disease progression on or after standard of care (immune checkpoint inhibitors alone or in combination with chemotherapy). Patients with actionable genomic alteration should have disease progression on approved therapy for these alterations, before using ANKTIVA in combination with immune checkpoint inhibitors.
This indication is approved under accelerated approval based on the increase of ALC associated with overall survival in single arm study. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory clinical trials.
Limitation of use:
Insufficient evidence of benefit for the use of ANKTIVA in combination with immune checkpoint inhibitors in NSCLC with baseline ALC < 1.0 × 10³/μL. Experience is limited to patients with a baseline absolute lymphocyte count (ALC) ≥ 1.0 × 10³/μL who are maintained above this level after treatments.
IMPORTANT SAFETY INFORMATION
INDICATION AND USAGE:
ANKTIVA® is an interleukin-15 (IL-15) receptor agonist indicated with Bacillus Calmette-Guérin (BCG) for the treatment of adult patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors.
WARNINGS AND PRECAUTIONS: Risk of Metastatic Bladder Cancer with Delayed Cystectomy. Delaying cystectomy can lead to the development of muscle-invasive or metastatic bladder cancer, which can be lethal. If patients with CIS do not have a complete response to treatment after a second induction course of ANKTIVA® with BCG, reconsider cystectomy.
DOSAGE AND ADMINISTRATION: For Intravesical Use Only. Do not administer by subcutaneous or intravenous routes.
Please see the complete Prescribing Information for ANKTIVA® at Anktiva.com.
About ImmunityBio
ImmunityBio is a vertically integrated biotechnology company developing next-generation therapies and vaccines that bolster the natural immune system to defeat cancers and infectious diseases. The company’s range of immunotherapy and cell therapy platforms, alone and together, act to drive and sustain an immune response to create durable and safe protection against disease. Designated an FDA Breakthrough Therapy, ANKTIVA® is the first FDA-approved immunotherapy for non-muscle invasive bladder cancer that activates natural killer cells, T cells, and memory T cells for a long-duration response. The company is applying its science and platforms to treating cancers, including the development of potential cancer vaccines, as well as developing immunotherapies and cell therapies that sharply reduce or eliminate the need for standard high-dose chemotherapy. For more information, please visit: www.ImmunityBio.com.
About Cigalah Healthcare:
Based in
About Biopharma Middle East and
Biopharma-mea is a regional
References:
- Saudi national lung cancer epidemiology from the Saudi Cancer Registry, 2015–2020 (AlOmar & AlAbdulKader, J Epidemiol Glob Health, 2025).
- Based on 2018 GLOBOCAN cancer incidence data reported in Cancer incidence and mortality estimates in Arab countries (medRxiv, 2022).
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements include, without limitation, our expectations regarding the anticipated commercial rollout of ANKTIVA® throughout the
These forward-looking statements are based on current expectations, assumptions, and projections that involve known and unknown risks and uncertainties that could cause actual results to differ materially from those expressed or implied. Such risks and uncertainties include, but are not limited to, risks related to the ability to obtain and maintain required regulatory approvals; pricing, reimbursement, and market access challenges across the
More details about these and other risks that may impact ImmunityBio’s business are described under the heading “Risk Factors” in the Company’s Form 10-K filed with the
View source version on businesswire.com:
ImmunityBio Contacts:
Investors
Hemanth Ramaprakash, PhD, MBA
ImmunityBio, Inc.
+1 858-746-9289
[email protected]
Media
Sarah Singleton
ImmunityBio, Inc.
+1 415-290-8045
[email protected]
Source: ImmunityBio, Inc.
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