ImmunityBio Announces UK Medicines and Healthcare Products Regulatory Agency Accepted Marketing Authorization Application for ANKTIVA® for the Treatment of Patients with BCG-unresponsive Non-Muscle Invasive Bladder Cancer Carcinoma In Situ
ImmunityBio (NASDAQ: IBRX) announced that the UK's Medicines and Healthcare products Regulatory Agency (MHRA) has validated and accepted the marketing authorization application for ANKTIVA®. The application is for ANKTIVA® in combination with BCG for treating patients with BCG-unresponsive non-muscle invasive bladder cancer with carcinoma in situ.
This acceptance follows the European Medicines Agency's recent review acceptance for 30 EU countries and comes 10 months after FDA approval in the United States. The MHRA will now begin assessing the marketing authorization application for potential approval in the UK market.
ImmunityBio (NASDAQ: IBRX) ha annunciato che l'Agenzia Regolatoria dei Medicinali e dei Prodotti Sanitari del Regno Unito (MHRA) ha validato e accettato la domanda di autorizzazione alla commercializzazione per ANKTIVA®. La domanda riguarda ANKTIVA® in combinazione con BCG per il trattamento di pazienti con cancro della vescica non muscolo invasivo non responsivo a BCG con carcinoma in situ.
Questa accettazione segue la recente revisione da parte dell'Agenzia Europea dei Medicinali per 30 paesi dell'UE e arriva 10 mesi dopo l'approvazione della FDA negli Stati Uniti. Ora la MHRA inizierà a valutare la domanda di autorizzazione alla commercializzazione per una possibile approvazione nel mercato del Regno Unito.
ImmunityBio (NASDAQ: IBRX) anunció que la Agencia Reguladora de Medicamentos y Productos Sanitarios del Reino Unido (MHRA) ha validado y aceptado la solicitud de autorización de comercialización para ANKTIVA®. La solicitud es para ANKTIVA® en combinación con BCG para tratar a pacientes con cáncer de vejiga no músculo invasivo que no responde a BCG y con carcinoma in situ.
Esta aceptación sigue a la reciente aceptación de revisión por parte de la Agencia Europea de Medicamentos para 30 países de la UE y llega 10 meses después de la aprobación de la FDA en los Estados Unidos. La MHRA ahora comenzará a evaluar la solicitud de autorización de comercialización para una posible aprobación en el mercado del Reino Unido.
ImmunityBio (NASDAQ: IBRX)는 영국의 의약품 및 건강관리 제품 규제 기관(MHRA)이 ANKTIVA®의 판매 허가 신청을 검증하고 수락했다고 발표했습니다. 이 신청은 BCG에 반응하지 않는 비근육 침습성 방광암 환자를 치료하기 위해 BCG와 함께 ANKTIVA®를 사용하는 것입니다.
이번 수락은 유럽 의약품청의 최근 30개 EU 국가에 대한 검토 수락에 이어지며, 미국 FDA의 승인이 있은 지 10개월 만에 이루어졌습니다. 이제 MHRA는 영국 시장에서의 잠재적 승인을 위해 판매 허가 신청을 평가하기 시작할 것입니다.
ImmunityBio (NASDAQ: IBRX) a annoncé que l'Agence britannique des médicaments et des produits de santé (MHRA) a validé et accepté la demande d'autorisation de mise sur le marché pour ANKTIVA®. La demande concerne ANKTIVA® en combinaison avec le BCG pour le traitement des patients atteints d'un cancer de la vessie non musculo-invasif ne répondant pas au BCG, avec carcinome in situ.
Cette acceptation fait suite à l'acceptation récente de la révision par l'Agence européenne des médicaments pour 30 pays de l'UE et intervient 10 mois après l'approbation de la FDA aux États-Unis. La MHRA commencera maintenant à évaluer la demande d'autorisation de mise sur le marché pour une approbation potentielle sur le marché britannique.
ImmunityBio (NASDAQ: IBRX) gab bekannt, dass die britische Arzneimittel- und Gesundheitsbehörde (MHRA) den Antrag auf Marktzulassung für ANKTIVA® validiert und akzeptiert hat. Der Antrag betrifft ANKTIVA® in Kombination mit BCG zur Behandlung von Patienten mit BCG-unempfindlichem nicht-muskelinvasivem Blasenkarzinom mit Carcinoma in situ.
Diese Akzeptanz folgt der kürzlichen Überprüfung durch die Europäische Arzneimittel-Agentur für 30 EU-Länder und erfolgt 10 Monate nach der Genehmigung durch die FDA in den Vereinigten Staaten. Die MHRA wird nun beginnen, den Antrag auf Marktzulassung auf eine mögliche Genehmigung im britischen Markt zu prüfen.
- MHRA acceptance of marketing authorization application for ANKTIVA in the UK market
- Recent EMA acceptance for review in 30 EU countries
- Existing FDA approval in the United States
- None.
Insights
The MHRA's acceptance of ANKTIVA's marketing authorization application marks a strategic expansion of ImmunityBio's global commercialization efforts, following FDA approval and EMA submission. This regulatory trifecta approach - US, EU, and UK - demonstrates exceptional execution in accessing major pharmaceutical markets within a compressed timeframe.
The rapid succession of regulatory submissions - FDA approval, EMA acceptance, and now MHRA validation within just 10 months - suggests a well-orchestrated regulatory strategy that could accelerate time-to-market across regions. This efficiency in regulatory navigation typically translates to faster revenue generation potential and stronger market positioning.
The UK market represents a significant opportunity in the bladder cancer treatment landscape. Non-muscle invasive bladder cancer patients who are unresponsive to BCG treatment have therapeutic options, making ANKTIVA's potential approval particularly valuable. The combination therapy approach with BCG could establish ANKTIVA as a standard of care in this specific patient population.
From a commercial perspective, securing access to the UK market would add another revenue stream to ImmunityBio's portfolio. The company's strategic approach of pursuing multiple major markets simultaneously indicates strong confidence in their clinical data package and manufacturing capabilities. This geographical diversification strategy could help mitigate market-specific risks and maximize the commercial potential of ANKTIVA.
“MHRA’s acceptance of our marketing authorization application for the
About ANKTIVA®
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 drives the activation and proliferation of NK cells with the generation of memory killer T cells that have retained immune memory against these tumor clones. The proliferation of the trifecta of these immune killing cells and the activation of trained immune memory results in immunogenic cell death, inducing a state of equilibrium with durable complete responses. ANKTIVA has improved pharmacokinetic properties, longer persistence in lymphoid tissues, and enhanced anti-tumor activity compared to native, non-complexed IL-15 in-vivo.
ANKTIVA was approved by the FDA in 2024 for BCG-unresponsive non-muscle invasive bladder cancer CIS with or without papillary tumors. For more information, visit ImmunityBio.com (Founder’s Vision) and 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 with the goal of creating durable and safe protection against disease. Designated an FDA Breakthrough Therapy, ANKTIVA is the first FDA-approved immunotherapy for non-muscle invasive bladder cancer CIS 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 we believe sharply reduce or eliminate the need for standard high-dose chemotherapy. These platforms and their associated product candidates are designed to be more effective, accessible, and easily administered than current standards of care in oncology and infectious diseases. For more information, visit ImmunityBio.com (Founder’s Vision) and connect with us on X (Twitter), Facebook, LinkedIn, and Instagram.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, such as statements regarding the anticipated timing of the MHRA’s review of ImmunityBio’s MAA and ultimate decision regarding whether to approve ANKTIVA for the treatment of patients with BCG-unresponsive NMIBC CIS in the territory under its jurisdiction, additional regulatory submissions and timing thereof, global expansion efforts, clinical trial data and potential results to be drawn therefrom, the development of therapeutics for cancer and infectious diseases, potential benefits to patients, potential treatment outcomes for patients, the described mechanism of action and results and contributions therefrom, potential future uses and applications of ANKTIVA and use in cancer vaccines and across multiple tumor types, and ImmunityBio’s approved product and investigational agents as compared to existing treatment options, among others. Statements in this press release that are not statements of historical fact are considered forward-looking statements, which are usually identified by the use of words such as “anticipates,” “believes,” “continues,” “goal,” “could,” “estimates,” “scheduled,” “expects,” “intends,” “may,” “plans,” “potential,” “predicts,” “indicate,” “projects,” “is,” “seeks,” “should,” “will,” “strategy,” and variations of such words or similar expressions. Statements of past performance, efforts, or results of our preclinical and clinical trials, about which inferences or assumptions may be made, can also be forward-looking statements and are not indicative of future performance or results. Forward-looking statements are neither forecasts, promises nor guarantees, and are based on the current beliefs of ImmunityBio’s management as well as assumptions made by and information currently available to ImmunityBio. Such information may be limited or incomplete, and ImmunityBio’s statements should not be read to indicate that it has conducted a thorough inquiry into, or review of, all potentially available relevant information. Such statements reflect the current views of ImmunityBio with respect to future events and are subject to known and unknown risks, including business, regulatory, economic and competitive risks, uncertainties, contingencies and assumptions about ImmunityBio, including, without limitation, (i) risks and uncertainties regarding the MHRA regulatory review process, potential actions required in connection with the same, and whether or not the MHRA will ultimately approve ImmunityBio’s MAA that has been accepted for review, (ii) risks and uncertainties regarding commercial launch execution, success and timing, (iii) risks and uncertainties related to the regulatory submission, filing and review process and the timing thereof, (iv) the ability of ImmunityBio to fund its ongoing and anticipated clinical trials, (v) whether clinical trials will result in registrational pathways, (vi) whether clinical trial data will be accepted by regulatory agencies, (vii) the ability of ImmunityBio to continue its planned preclinical and clinical development of its development programs through itself and/or its investigators, and the timing and success of any such continued preclinical and clinical development, patient enrollment and planned regulatory submissions, (viii) potential delays in product availability and regulatory approvals, (ix) ImmunityBio’s ability to retain and hire key personnel, (x) ImmunityBio’s ability to obtain additional financing to fund its operations and complete the development and commercialization of its various product candidates, (xi) potential product shortages or manufacturing disruptions that may impact the availability and timing of product, (xii) ImmunityBio’s ability to successfully commercialize its approved product and product candidates, (xiii) ImmunityBio’s ability to scale its manufacturing and commercial supply operations for its approved product and future approved products, and (xiv) ImmunityBio’s ability to obtain, maintain, protect, and enforce patent protection and other proprietary rights for its product candidates and technologies. 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
Indication and Important Safety Information
INDICATION AND USAGE: ANKTIVA is an interleukin-15 (IL-15) receptor agonist indicated with Bacillus Calmette-Guerin (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 patient 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 lntravesical Use Only. Do not administer by subcutaneous or intravenous routes. Instill intravesically only after dilution. Total time from vial puncture to the completion of the intravesical instillation should not exceed 2 hours.
USE IN SPECIFIC POPULATIONS: Pregnancy: May cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception.
ADVERSE REACTIONS: The most common (≥
For more information about ANKTIVA, please see the Full Prescribing Information at www.anktiva.com.
You are encouraged to report negative side effects of prescription drugs to FDA.
Visit www.FDA.gov/medwatch or call 1-800-332-1088. You may also contact lmmunityBio at 1-877-ANKTIVA (1-877-265-8482).
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Investors
Hemanth Ramaprakash, PhD, MBA
ImmunityBio, Inc.
+1 858-746-9289
Hemanth.Ramaprakash@ImmunityBio.com
Media
Sarah Singleton
ImmunityBio, Inc.
+1 415-290-8045
Sarah.Singleton@ImmunityBio.com
Source: ImmunityBio, Inc.
FAQ
What is the status of ANKTIVA's regulatory approval in the UK for IBRX?
What markets has ANKTIVA received regulatory acceptance or approval for IBRX?
What indication is ANKTIVA seeking approval for in the UK market?
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