Replimune Announces Biologics License Application Acceptance and Priority Review for RP1 for the Treatment of Advanced Melanoma
Replimune Group (NASDAQ: REPL) announced FDA acceptance of its Biologics License Application (BLA) for RP1 (vusolimogene oderparepvec) in combination with nivolumab for advanced melanoma treatment, with Priority Review status and a PDUFA date of July 22, 2025.
The FDA indicated no current plans for an advisory committee meeting and hasn't identified potential review issues. The application is supported by primary analysis data from the IGNYTE trial, which evaluated RP1 with nivolumab in anti-PD-1 failed melanoma patients. A confirmatory Phase 3 trial, IGNYTE-3, is ongoing with over 100 planned global sites.
The company recently received Breakthrough Therapy designation for this combination treatment, based on safety and clinical activity observed in the IGNYTE trial's anti-PD-1 failed melanoma cohort.
Replimune Group (NASDAQ: REPL) ha annunciato l'accettazione da parte della FDA della sua Domanda di Licenza Biologica (BLA) per RP1 (vusolimogene oderparepvec) in combinazione con nivolumab per il trattamento del melanoma avanzato, con stato di revisione prioritaria e una data PDUFA del 22 luglio 2025.
La FDA ha indicato che non ci sono attualmente piani per una riunione del comitato consultivo e non ha identificato potenziali problemi di revisione. La domanda è supportata dai dati dell'analisi primaria dello studio IGNYTE, che ha valutato RP1 con nivolumab in pazienti con melanoma che non hanno risposto al trattamento anti-PD-1. Uno studio di conferma di Fase 3, IGNYTE-3, è attualmente in corso con oltre 100 siti globali pianificati.
L'azienda ha recentemente ricevuto la designazione di terapia innovativa per questo trattamento combinato, basata sulla sicurezza e sull'attività clinica osservata nel cohort di pazienti con melanoma fallito al trattamento anti-PD-1 nello studio IGNYTE.
Replimune Group (NASDAQ: REPL) anunció la aceptación por parte de la FDA de su Solicitud de Licencia Biológica (BLA) para RP1 (vusolimogene oderparepvec) en combinación con nivolumab para el tratamiento de melanoma avanzado, con estatus de Revisión Prioritaria y una fecha PDUFA del 22 de julio de 2025.
La FDA indicó que no hay planes actuales para una reunión del comité asesor y no ha identificado problemas potenciales de revisión. La aplicación está respaldada por datos de análisis primario del ensayo IGNYTE, que evaluó RP1 con nivolumab en pacientes con melanoma fallido al tratamiento anti-PD-1. Un ensayo de confirmación de Fase 3, IGNYTE-3, está en curso con más de 100 sitios globales planificados.
La compañía recibió recientemente la designación de Terapia Innovadora para este tratamiento combinado, basado en la seguridad y la actividad clínica observadas en la cohorte de melanoma fallido al tratamiento anti-PD-1 en el ensayo IGNYTE.
Replimune Group (NASDAQ: REPL)는 RP1(부솔리모겐 오더페펙)와 니볼루맙을 병용한 진행성 흑색종 치료를 위한 생물학적 라이센스 신청서(BLA)가 FDA에 수락되었음을 발표했습니다. 이 신청서는 우선 검토 상태를 부여받았으며, PDUFA 날짜는 2025년 7월 22일입니다.
FDA는 현재 자문 위원회 회의에 대한 계획이 없으며 검토 문제를 파악하지 않았다고 밝혔습니다. 이 신청서는 RP1과 니볼루맙을 평가한 IGNYTE 시험의 주요 분석 데이터에 의해 지원됩니다. 현재 100개 이상의 전 세계적인 사이트가 예정된 확인적 3상 시험인 IGNYTE-3가 진행 중입니다.
회사는 최근 IGNYTE 시험의 항-PD-1 실패 흑색종 코호트에서 관찰된 안전성 및 임상 활동을 기반으로 이 병용 치료에 대한 혁신 치료 지정을 받았습니다.
Replimune Group (NASDAQ: REPL) a annoncé que la FDA a accepté sa Demande de Licence Biologique (BLA) pour RP1 (vusolimogene oderparepvec) en combinaison avec le nivolumab pour le traitement du mélanome avancé, avec un statut de Révision Prioritaire et une date PDUFA du 22 juillet 2025.
La FDA n’a actuellement aucun plan pour une réunion du comité consultatif et n’a pas identifié de problèmes potentiels de révision. La demande est soutenue par des données d’analyse primaire de l'essai IGNYTE, qui a évalué RP1 avec le nivolumab chez des patients atteints de mélanome ayant échoué au traitement anti-PD-1. Une étude de confirmation de Phase 3, IGNYTE-3, est en cours avec plus de 100 sites mondiaux prévus.
La société a récemment reçu la designation de thérapie révolutionnaire pour ce traitement combiné, basé sur la sécurité et l'activité clinique observées dans la cohorte de mélanome échoué au traitement anti-PD-1 de l'essai IGNYTE.
Replimune Group (NASDAQ: REPL) gab die Annahme seines Biologics-Lizenzantrags (BLA) für RP1 (vusolimogene oderparepvec) in Kombination mit Nivolumab zur Behandlung von fortgeschrittenem Melanom bekannt, mit Prioritätsprüfungsstatus und einem PDUFA-Datum vom 22. Juli 2025.
Die FDA hat keine aktuellen Pläne für eine Sitzung des Beraterkomitees angekündigt und hat keine potenziellen Prüfungsprobleme identifiziert. Der Antrag wird durch Primäranalysedaten aus der IGNYTE-Studie unterstützt, die RP1 mit Nivolumab bei Melanom-Patienten, die auf anti-PD-1 nicht angesprochen haben, bewertet hat. Eine bestätigende Phase-3-Studie, IGNYTE-3, ist mit über 100 geplanten globalen Standorten im Gange.
Das Unternehmen hat kürzlich die Bezeichnung als Durchbruchtherapie für diese Kombinationstherapie erhalten, basierend auf der Sicherheit und der klinischen Aktivität, die in der IGNYTE-Studie bei der Kohorte der anti-PD-1 erfolglosen Melanompatienten beobachtet wurden.
- FDA granted Priority Review status, potentially expediting the approval process
- FDA indicated no current review issues or need for advisory committee meeting
- Received Breakthrough Therapy designation for RP1-nivolumab combination
- Large-scale confirmatory Phase 3 trial already underway with 100+ global sites
- Final FDA approval still pending and subject to review process
- Confirmatory Phase 3 trial results not yet available
Insights
The FDA's acceptance of Replimune's BLA with Priority Review status for RP1 represents a pivotal regulatory milestone with substantial market implications. Priority Review designation reduces the standard review time from 10 months to 6 months, potentially accelerating market entry. The absence of planned advisory committee meetings and no identified review issues are particularly encouraging signals for approval probability.
The addressable market for RP1 in advanced melanoma is significant, targeting patients who have failed anti-PD-1 therapy - a growing segment with treatment options. The combination therapy approach with nivolumab could position RP1 as a key second-line treatment option. The ongoing IGNYTE-3 confirmatory trial, with its expansive 100-site global footprint, demonstrates robust clinical development infrastructure and potential for label expansion.
For retail investors: Think of Priority Review as a "fast pass" at an amusement park - it significantly shortens the waiting time for potential market entry. The FDA's decision to skip an advisory committee meeting suggests they see a straightforward path to approval, similar to having a clear runway for landing.
The regulatory pathway for RP1 shows several positive indicators that enhance approval probability. The Breakthrough Therapy designation combined with Priority Review status reflects the FDA's recognition of RP1's potential clinical impact. The absence of identified review issues at this stage and waiver of an advisory committee meeting typically suggests the FDA views the submission package as robust and the risk-benefit profile as favorable.
The PDUFA date of July 22, 2025 provides a clear timeline for potential commercialization planning. The concurrent execution of the confirmatory Phase 3 IGNYTE-3 trial demonstrates strategic regulatory planning, as positive results could strengthen post-approval market position and potentially expand indications.
Simple explanation: When the FDA fast-tracks a review and doesn't need extra meetings to discuss concerns, it's like getting pre-approved for a loan - there are still steps to complete, but the major hurdles have been cleared.
PDUFA action date of July 22, 2025, with priority review
WOBURN, Mass., Jan. 21, 2025 (GLOBE NEWSWIRE) -- Replimune Group, Inc. (NASDAQ: REPL), a clinical stage biotechnology company pioneering the development of novel oncolytic immunotherapies, today announced that the U.S. Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for RP1 (vusolimogene oderparepvec) in combination with nivolumab for patients with advanced melanoma. The FDA granted the BLA Priority Review with a Prescription Drug User Fee Act (PDUFA) action date of July 22, 2025. The FDA also informed the Company that they are not currently planning to hold an advisory committee meeting in relation to this application, and at this time have not identified any potential review issues. The BLA is supported by the primary analysis data of the IGNYTE trial, evaluating RP1 combined with nivolumab in patients with anti-PD-1 failed melanoma. A confirmatory Phase 3 trial, IGNYTE-3, is currently underway with over 100 sites planned globally.
“There are limited treatment options and a significant unmet need for patients with advanced melanoma who previously received an anti-PD-1 containing regimen,” said Sushil Patel, Ph.D., Chief Executive Officer, Replimune. “The BLA acceptance is an important milestone for Replimune, and we look forward to working closely with the FDA on the review of our application.”
The FDA grants Priority Review to applications for medicines that, if approved, provide significant improvements in the safety or effectiveness of the treatment of a serious condition. Recently, Replimune received Breakthrough Therapy designation for RP1 in combination with nivolumab for the treatment of advanced melanoma, based on the safety and clinical activity observed in the anti-PD-1 failed melanoma cohort of the IGNYTE clinical trial.
The confirmatory IGNYTE-3 trial is assessing RP1 in combination with nivolumab in patients with advanced melanoma who have progressed on anti-PD-1 and anti-CTLA-4 therapies or are ineligible for anti-CTLA-4 treatment. For more information, please visit https://replimune.com/clinical-trials/ignyte-3/.
About Melanoma
Melanoma is the fifth most common cancer, with approximately 100,000 new cases and 8,000 deaths estimated in the U.S. in 2024.i Standard of care therapy includes treatment with immune checkpoint blockade, to which approximately half of patients will not respond or will progress after treatment. Options are limited after immune checkpoint blockade therapy, with no standard of care available to patients.
About RP1
RP1 (vusolimogene oderparepvec) is Replimune’s lead product candidate and is based on a proprietary strain of herpes simplex virus engineered and genetically armed with a fusogenic protein (GALV-GP R-) and GM-CSF, intended to maximize tumor killing potency, the immunogenicity of tumor cell death, and the activation of a systemic anti-tumor immune response.
About Replimune
Replimune Group, Inc., headquartered in Woburn, MA, was founded in 2015 with the mission to transform cancer treatment by pioneering the development of novel oncolytic immunotherapies. Replimune’s proprietary RPx platform is based on a potent HSV-1 backbone intended to maximize immunogenic cell death and the induction of a systemic anti-tumor immune response. The RPx platform is designed to have a unique dual local and systemic activity consisting of direct selective virus-mediated killing of the tumor resulting in the release of tumor derived antigens and altering of the tumor microenvironment to ignite a strong and durable systemic response. The RPx product candidates are expected to be synergistic with most established and experimental cancer treatment modalities, leading to the versatility to be developed alone or combined with a variety of other treatment options. For more information, please visit www.replimune.com.
Forward Looking Statements
This press release contains forward looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, including statements regarding the design and advancement of our clinical trials, the timing and sufficiency of our clinical trial outcomes to support potential approval of any of our product candidates, the FDA review process, review timing and outcome of our BLA, our goals to develop and commercialize our product candidates, patient enrollments in our existing and planned clinical trials and the timing thereof, and other statements identified by words such as “could,” “expects,” “intends,” “may,” “plans,” “potential,” “should,” “will,” “would,” or similar expressions and the negatives of those terms. Forward-looking statements are not promises or guarantees of future performance, and are subject to a variety of risks and uncertainties, many of which are beyond our control, and which could cause actual results to differ materially from those contemplated in such forward-looking statements. These factors include risks related to our limited operating history, our ability to generate positive clinical trial results for our product candidates, the costs and timing of operating our in-house manufacturing facility, the timing and scope of regulatory approvals, the availability of combination therapies needed to conduct our clinical trials, changes in laws and regulations to which we are subject, competitive pressures, our ability to identify additional product candidates, political and global macro factors including the impact of the coronavirus as a global pandemic and related public health issues and the Russian-Ukrainian and Israel-Hamas political and military conflicts, and other risks as may be detailed from time to time in our Annual Reports on Form 10-K and Quarterly Reports on Form 10-Q and other reports we file with the Securities and Exchange Commission. Our actual results could differ materially from the results described in or implied by such forward-looking statements. Forward-looking statements speak only as of the date hereof, and, except as required by law, we undertake no obligation to update or revise these forward-looking statements.
Investor Inquiries
Chris Brinzey
ICR Healthcare
339.970.2843
chris.brinzey@icrhealthcare.com
Media Inquiries
Arleen Goldenberg
Replimune
917.548.1582
media@replimune.com
i American Cancer Society. “Cancer Facts and Figures 2024”. Atlanta: American Cancer Society; 2024.
FAQ
When is the PDUFA date for Replimune's (REPL) RP1 melanoma treatment?
What designations has Replimune (REPL) received for its RP1 melanoma treatment?
What is the status of Replimune's (REPL) IGNYTE-3 trial?
What patient population is Replimune's (REPL) RP1 treatment targeting?
