Alpha Tau Announces Acceptance Into FDA’s Total Product Life Cycle Advisory Program to Accelerate Market Access to Alpha DaRT® for Patients with Recurrent Glioblastoma Multiforme
Alpha Tau Medical (NASDAQ: DRTS, DRTSW) has been accepted into the FDA's Total Product Life Cycle (TPLC) Advisory Program (TAP) Pilot to accelerate market access for Alpha DaRT® in treating recurrent glioblastoma multiforme (GBM). This follows the company's previous Breakthrough Device Designation for this indication. TAP aims to expedite patient access to innovative medical devices by providing early, frequent, and strategic communications with the FDA and facilitating engagement with key stakeholders.
The program offers tailored assistance from FDA TAP advisors to advance devices to market, focusing on product lifecycle regulation, payer coverage policies, and integration of patient insights. With an estimated 14,000 new GBM diagnoses per year in the U.S. and low five-year survival rates, Alpha Tau sees this as a important step in their strategy to treat internal organs with high unmet medical needs.
Alpha Tau Medical (NASDAQ: DRTS, DRTSW) è stata accettata nel Programma Pilota di Consulenza sul Ciclo di Vita Totale del Prodotto (TPLC) della FDA per accelerare l'accesso al mercato per Alpha DaRT® nel trattamento del glioblastoma multiforme ricorrente (GBM). Questo segue la Designazione di Dispositivo Innovativo precedentemente concessa dall'azienda per questa indicazione. Il TAP ha l'obiettivo di velocizzare l'accesso dei pazienti a dispositivi medici innovativi, fornendo comunicazioni anticipatorie, frequenti e strategiche con la FDA e facilitando l'engagement con i principali stakeholder.
Il programma offre assistenza personalizzata da parte degli esperti del TAP della FDA per avanzare i dispositivi sul mercato, concentrandosi sulla regolamentazione del ciclo di vita del prodotto, le politiche di copertura dei pagatori e l'integrazione delle opinioni dei pazienti. Con circa 14.000 nuove diagnosi di GBM all'anno negli Stati Uniti e basse percentuali di sopravvivenza a cinque anni, Alpha Tau considera questo un passo importante nella loro strategia per trattare gli organi interni con elevate esigenze mediche insoddisfatte.
Alpha Tau Medical (NASDAQ: DRTS, DRTSW) ha sido aceptada en el Programa Piloto de Asesoría sobre el Ciclo de Vida Total del Producto (TPLC) de la FDA para acelerar el acceso al mercado de Alpha DaRT® en el tratamiento del glioblastoma multiforme recurrente (GBM). Esto sigue a la Designación de Dispositivo Innovador que la compañía recibió anteriormente para esta indicación. El TAP tiene como objetivo agilizar el acceso de los pacientes a dispositivos médicos innovadores al proporcionar comunicaciones anticipadas, frecuentes y estratégicas con la FDA y facilitar el compromiso con las partes interesadas clave.
El programa ofrece asistencia personalizada de asesores del TAP de la FDA para avanzar los dispositivos al mercado, enfocándose en la regulación del ciclo de vida del producto, las políticas de cobertura de los pagadores y la integración de las opiniones de los pacientes. Con un estimado de 14,000 nuevos diagnósticos de GBM por año en EE.UU. y bajas tasas de supervivencia a cinco años, Alpha Tau ve esto como un paso importante en su estrategia para tratar órganos internos con altas necesidades médicas no satisfechas.
Alpha Tau Medical (NASDAQ: DRTS, DRTSW)은 FDA의 제품 전체 생애 주기(TPLC) 자문 프로그램(TAP) 파일럿에 수락되었습니다 이로 인해 Alpha DaRT®가 재발성 다형성 교모세포종(GBM) 치료를 위한 시장 접근이 가속화됩니다. 이는 이 적응증에 대한 돌파구 기기 지정 이전에 회사가 받은 것입니다. TAP의 목표는 FDA와의 조기, 빈번하고 전략적인 커뮤니케이션을 제공하고 주요 이해관계자와의 참여를 촉진함으로써 혁신적인 의료기기에 대한 환자의 접근을 신속하게 하는 것입니다.
이 프로그램은 제품 수명 주기 규제, 지불자 보장 정책 및 환자 통찰력 통합에 초점을 맞춰 시장으로의 기기 진전을 위한 FDA TAP 고문에 의한 맞춤형 지원을 제공합니다. 미국에서 매년 14,000건의 새로운 GBM 진단이 예상되고 낮은 5년 생존율을 감안할 때, Alpha Tau는 이를 내부 장기를 치료하기 위한 높은 미충족 의료 필요성을 충족하는 전략의 중요한 단계로 보고 있습니다.
Alpha Tau Medical (NASDAQ: DRTS, DRTSW) a été accepté dans le Programme Pilote de Conseil sur le Cycle de Vie Total du Produit (TPLC) de la FDA pour accélérer l'accès au marché pour Alpha DaRT® dans le traitement du glioblastome multiforme récurrent (GBM). Cela fait suite à la Désignation de Dispositif Innovant précédemment accordée à l'entreprise pour cette indication. Le TAP vise à accélérer l'accès des patients à des dispositifs médicaux innovants en fournissant des communications précoces, fréquentes et stratégiques avec la FDA et en facilitant l'engagement avec les principales parties prenantes.
Le programme offre une assistance personnalisée des conseillers TAP de la FDA pour faire avancer les dispositifs sur le marché, en se concentrant sur la réglementation du cycle de vie des produits, les politiques de couverture des payeurs et l'intégration des avis des patients. Avec environ 14 000 nouveaux diagnostics de GBM par an aux États-Unis et de faibles taux de survie à cinq ans, Alpha Tau considère cela comme une étape importante de sa stratégie pour traiter les organes internes présentant de grandes besoins médicaux non satisfaits.
Alpha Tau Medical (NASDAQ: DRTS, DRTSW) wurde in das Pilotprogramm der FDA für Beratung zum gesamten Produktlebenszyklus (TPLC) aufgenommen, um den Marktzugang für Alpha DaRT® zur Behandlung von rezidivierendem Glioblastom multiforme (GBM) zu beschleunigen. Dies folgt auf die Durchbruch-Geräte-Designierung des Unternehmens für diese Indikation. Das TAP zielt darauf ab, den Zugang der Patienten zu innovativen Medizinprodukten zu beschleunigen, indem es frühzeitige, häufige und strategische Kommunikation mit der FDA bereitstellt und die Einbindung mit wichtigen Interessengruppen erleichtert.
Das Programm bietet maßgeschneiderte Unterstützung von FDA TAP-Beratern, um Geräte auf den Markt zu bringen und sich auf die Regulierung des Produktlebenszyklus, politische Bereiche der Kostenträger und die Integration von Patientenmeinungen zu konzentrieren. Mit geschätzten 14.000 neuen GBM-Diagnosen pro Jahr in den USA und niedrigen Fünfjahresüberlebensraten betrachtet Alpha Tau dies als einen wichtigen Schritt in ihrer Strategie zur Behandlung innerer Organe mit hohen unbefriedigten medizinischen Bedürfnissen.
- Acceptance into FDA's TAP Pilot program for Alpha DaRT®
- Potential acceleration of market access for recurrent GBM treatment
- Previous Breakthrough Device Designation from FDA
- Tailored assistance from FDA TAP advisors
- Large potential market with 14,000 new GBM diagnoses per year in the U.S.
- None.
Insights
The acceptance of Alpha Tau's Alpha DaRT® therapy into the FDA's Total Product Life Cycle (TPLC) Advisory Program is a significant milestone for the company's development in treating recurrent glioblastoma multiforme (GBM). This program aims to accelerate market access and patient availability for innovative medical devices.
Key points to consider:
- The Alpha DaRT® therapy has already received Breakthrough Device Designation from the FDA for GBM treatment, highlighting its potential impact.
- TAP provides strategic communications with the FDA and engagement with key stakeholders, potentially reducing time, cost and uncertainty in the path to market.
- With approximately 14,000 new GBM diagnoses annually in the U.S. and low survival rates, there's a critical need for innovative therapies.
- This development could significantly accelerate Alpha Tau's commercialization timeline and market penetration for GBM treatment.
While this news is promising, investors should note that it does not guarantee FDA approval or commercial success. However, it does indicate a potentially smoother regulatory pathway and increased visibility for Alpha Tau's technology in the oncology space.
JERUSALEM, Oct. 21, 2024 (GLOBE NEWSWIRE) -- Alpha Tau Medical Ltd. ("Alpha Tau", or the “Company”) (NASDAQ: DRTS, DRTSW), the developer of the innovative alpha-emitters cancer therapy Alpha DaRT®, announced today that it has been accepted into the prestigious Total Product Life Cycle (TPLC) Advisory Program (“TAP”) Pilot of the U.S. Food and Drug Administration (“FDA”), to accelerate market access to the Alpha DaRT for patients with recurrent glioblastoma multiforme (“GBM”). This acceptance follows the Company’s previous receipt of Breakthrough Device Designation from the FDA for this indication, one of two such designations received for the Alpha DaRT, and a pre-requisite for application to the TAP program.
TAP’s primary goal is to expedite and enable patient access to innovative and highly promising medical devices which are not currently on the market by providing early, frequent, and strategic communications with the FDA, and by facilitating engagement with other key parties for developers of devices of public health importance, with an eye toward reducing the time, cost and uncertainty of patient access through reimbursement and commercial adoption following FDA authorization. To achieve this goal, a dedicated cadre of FDA TAP advisors are selected to provide tailored and solutions-focused assistance to advance these devices to market and patient access, and to offer their expertise in areas including product lifecycle regulation, payer coverage policies, industry experience, physician provider group or specialty society connectivity, and integration of patient insights.
“As Alpha Tau intensifies its ongoing focus on treating internal organs with tremendous unmet need, and advances further towards commercialization of the Alpha DaRT, this exciting announcement comes at exactly the right time,” said Alpha Tau Chief Executive Officer Uzi Sofer. “With an estimated 14,000 new GBM diagnoses per year in the U.S., and exceedingly low five-year survival rates, the need to expedite access to new innovative therapies is clear. We are delighted to have been selected by the FDA and are hopeful that the guidance from this distinguished panel of advisors will be immensely valuable in crafting our GBM strategy for maximal impact in the commercial market for patients with such a devastating disease.”
About Alpha DaRT®
Alpha DaRT (Diffusing Alpha-emitters Radiation Therapy) is designed to enable highly potent and conformal alpha-irradiation of solid tumors by intratumoral delivery of radium-224 impregnated sources. When the radium decays, its short-lived daughters are released from the sources and disperse while emitting high-energy alpha particles with the goal of destroying the tumor. Since the alpha-emitting atoms diffuse only a short distance, Alpha DaRT aims to mainly affect the tumor, and to spare the healthy tissue around it.
About Alpha Tau Medical Ltd.
Founded in 2016, Alpha Tau is an Israeli oncology therapeutics company that focuses on research, development, and potential commercialization of the Alpha DaRT for the treatment of solid tumors. The technology was initially developed by Prof. Itzhak Kelson and Prof. Yona Keisari from Tel Aviv University.
Forward-Looking Statements
This press release includes "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. When used herein, words including "anticipate," "being," "will," "plan," "may," "continue," and similar expressions are intended to identify forward-looking statements. In addition, any statements or information that refer to expectations, beliefs, plans, projections, objectives, performance or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking. All forward-looking statements are based upon Alpha Tau's current expectations and various assumptions. Alpha Tau believes there is a reasonable basis for its expectations and beliefs, but they are inherently uncertain. Alpha Tau may not realize its expectations, and its beliefs may not prove correct. Actual results could differ materially from those described or implied by such forward-looking statements as a result of various important factors, including, without limitation: (i) Alpha Tau's ability to receive regulatory approval for its Alpha DaRT technology or any future products or product candidates; (ii) Alpha Tau's limited operating history; (iii) Alpha Tau's incurrence of significant losses to date; (iv) Alpha Tau's need for additional funding and ability to raise capital when needed; (v) Alpha Tau's limited experience in medical device discovery and development; (vi) Alpha Tau's dependence on the success and commercialization of the Alpha DaRT technology; (vii) the failure of preliminary data from Alpha Tau's clinical studies to predict final study results; (viii) failure of Alpha Tau's early clinical studies or preclinical studies to predict future clinical studies; (ix) Alpha Tau's ability to enroll patients in its clinical trials; (x) undesirable side effects caused by Alpha Tau's Alpha DaRT technology or any future products or product candidates; (xi) Alpha Tau's exposure to patent infringement lawsuits; (xii) Alpha Tau's ability to comply with the extensive regulations applicable to it; (xiii) the ability to meet Nasdaq's listing standards; (xiv) costs related to being a public company; (xv) changes in applicable laws or regulations; and the other important factors discussed under the caption "Risk Factors" in Alpha Tau's annual report filed on form 20-F with the SEC on March 7, 2024, and other filings that Alpha Tau may make with the United States Securities and Exchange Commission. These and other important factors could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management's estimates as of the date of this press release. While Alpha Tau may elect to update such forward-looking statements at some point in the future, except as required by law, it disclaims any obligation to do so, even if subsequent events cause its views to change. These forward-looking statements should not be relied upon as representing Alpha Tau's views as of any date subsequent to the date of this press release.
Investor Relations Contact:
IR@alphatau.com
FAQ
What is Alpha Tau's Alpha DaRT® therapy being developed for?
What FDA program has Alpha Tau (DRTS) been accepted into?
How many new GBM diagnoses are estimated per year in the U.S.?
What is the goal of the FDA's TAP program for Alpha Tau's Alpha DaRT®?
