This section highlights FDA-related milestones and regulatory updates for drugs developed by Replimune Group (REPL).
Over the past two years, Replimune Group has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
RP1 and RP1. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
RP1 (vusolimogene oderparepvec) FDA Regulatory Timeline and Events
RP1 (vusolimogene oderparepvec) is a drug developed by Replimune Group for the following indication: In Advanced Melanoma.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- RP1 (vusolimogene oderparepvec)
- Announced Date:
- July 22, 2025
- Indication:
- In Advanced Melanoma
Announcement
Replimune Group announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) regarding the Biologics License Application (BLA) for RP1 (vusolimogene oderparepvec) in combination with nivolumab for the treatment of advanced melanoma.
AI Summary
Replimune Group announced that the U.S. Food and Drug Administration has issued a Complete Response Letter for its Biologics License Application of RP1 (vusolimogene oderparepvec) combined with nivolumab to treat advanced melanoma. The FDA said it cannot approve the application in its current form.
The agency found that the IGNYTE trial did not provide strong, well-controlled evidence of effectiveness and could not be properly interpreted because of patient differences. It also highlighted concerns about the design of the planned confirmatory trial, including how each treatment component contributes to the overall effect. Importantly, no safety issues were raised.
Replimune plans to request a Type A meeting within 30 days and will work closely with the FDA to pursue accelerated approval. CEO Sushil Patel said the company is surprised by the decision and remains confident that RP1 plus nivolumab can offer real benefits to patients with limited treatment options.
Read Announcement- Drug:
- RP1 (vusolimogene oderparepvec)
- Announced Date:
- June 1, 2025
- Indication:
- In Advanced Melanoma
Announcement
Replimune Group, today presented two posters highlighting data updates for RP1 (vusolimogene oderparepvec) at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting taking place May 30-June 3 in Chicago.
AI Summary
Replimune Group presented two posters at the 2025 ASCO Annual Meeting in Chicago that highlighted new data on their lead oncolytic immunotherapy, RP1 (vusolimogene oderparepvec), when used with nivolumab. The posters detailed findings from the IGNYTE clinical trial in patients with melanoma that had failed anti-PD-1 therapy. Notably, the study showed that deep or visceral injections—targeting tumors in the liver and lung—resulted in higher response rates compared to superficial injections alone. Both injected and non-injected lesions demonstrated robust responses, supporting the idea that RP1 can trigger a strong systemic anti-tumor effect. Additionally, the posters confirmed that RP1 is safe to handle, as standard disinfection methods effectively neutralize the virus, minimizing any risk of transmission.
Read Announcement- Drug:
- RP1 (vusolimogene oderparepvec)
- Announced Date:
- January 21, 2025
- Indication:
- In Advanced Melanoma
Announcement
Replimune Group 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.
AI Summary
Replimune Group announced that the FDA has accepted its Biologics License Application (BLA) for RP1 (vusolimogene oderparepvec) in combination with nivolumab for patients with advanced melanoma. This important step targets those who have not responded well to previous anti-PD-1 therapies. The FDA granted a Priority Review for the BLA, setting a Prescription Drug User Fee Act (PDUFA) action date of July 22, 2025. Notably, the FDA is not planning an advisory committee meeting and has not identified any potential issues with the review. The application is supported by primary data from the IGNYTE trial, which evaluated the safety and effectiveness of the combination therapy in patients with limited treatment options. Replimune looks forward to working closely with the FDA as the review process continues, representing a hopeful development for patients with advanced melanoma.
Read Announcement- Drug:
- RP1 (vusolimogene oderparepvec)
- Announced Date:
- November 22, 2024
- Indication:
- In Advanced Melanoma
Announcement
Replimune Group, Inc. announced that it has submitted a biologics license application (BLA) to the FDA for RP1 (vusolimogene oderparepvec) in combination with nivolumab for the treatment of adult patients with advanced melanoma who have previously received an anti-PD1 containing regimen.
AI Summary
Replimune Group, Inc. has taken a significant step in developing new treatments for advanced melanoma. The company submitted a biologics license application (BLA) to the FDA for its lead product candidate, RP1 (vusolimogene oderparepvec), when used in combination with nivolumab. This treatment is aimed at adult patients with advanced melanoma who have already undergone an anti-PD1 treatment regimen. The submission, made under the Accelerated Approval pathway, highlights the potential of the RP1 and nivolumab combination as an alternative for patients with limited treatment options. Early clinical evidence has shown encouraging results in safety and tumor response, supporting the further development of this therapy. This move could eventually provide a much-needed option for patients who have not responded to earlier therapies.
Read Announcement- Drug:
- RP1 (vusolimogene oderparepvec)
- Announced Date:
- September 9, 2024
- Estimated Event Date Range:
- July 1, 2024 - December 31, 2024
- Target Action Date:
- H2 2024
- Indication:
- In Advanced Melanoma
Announcement
Replimune Group, Inc. accelerated approval pathway in 2H 2024.
AI Summary
Replimune Group, Inc. has received confirmation from the FDA that its lead product candidate, RP1, can follow the accelerated approval pathway for treating anti-PD1 failed melanoma. The successful pre-BLA meeting supports the company’s strategy to file a Biologics License Application (BLA) in the second half of 2024. Replimune’s CEO, Dr. Sushil Patel, emphasized that the meeting reaffirmed RP1’s eligibility for accelerated approval, which is a critical step in expediting the drug’s availability for patients with advanced melanoma. With the IGNYTE-3 clinical trial already underway and showing promising results, the company is focused on meeting regulatory milestones and bringing a new treatment option to patients in need.
Read Announcement- Drug:
- RP1 (vusolimogene oderparepvec)
- Announced Date:
- September 9, 2024
- Indication:
- In Advanced Melanoma
Announcement
Replimune Group, Inc. announced it has completed a successful pre-Biologics License Application (pre-BLA) meeting with the U.S. Food and Drug Administration (FDA) that supports the Company's plans to submit a BLA for RP1 (vusolimogene oderparepvec) for the treatment of anti-PD1 failed melanoma
AI Summary
Replimune Group, Inc. announced that it has completed a successful pre-Biologics License Application (pre-BLA) meeting with the U.S. Food and Drug Administration (FDA). This meeting confirmed that the accelerated approval pathway is available for its lead product candidate, RP1 (vusolimogene oderparepvec), designed for the treatment of melanoma patients who have not responded to anti-PD1 therapies. The positive outcome from the FDA meeting supports the company’s plan to submit a Biologics License Application (BLA) for RP1 in the second half of 2024. RP1, which employs an engineered herpes simplex virus to trigger tumor killing and boost the immune response, is currently being evaluated in clinical trials. This milestone is a significant step for Replimune as it prepares to bring a potentially life-changing treatment option to patients with advanced melanoma.
Read Announcement- Drug:
- RP1 (vusolimogene oderparepvec)
- Announced Date:
- August 13, 2024
- Indication:
- In Advanced Melanoma
Announcement
Replimune Group, Inc announced that the first patient has been randomized and dosed in the IGNYTE-3 study – a global Phase 3 clinical trial assessing the efficacy and safety of RP1 (vusolimogene oderparepvec) plus nivolumab in patients with advanced melanoma who have progressed on anti-PD1 and anti-CTLA-4 drugs or are ineligible for anti-CTLA-4 treatment..
AI Summary
Replimune Group, Inc. announced that the first patient has been randomized and dosed in the global Phase 3 IGNYTE-3 study. This trial is designed to evaluate the safety and effectiveness of RP1 (vusolimogene oderparepvec) combined with nivolumab in patients with advanced melanoma. The study focuses on patients who have either progressed after treatment with anti-PD1 and anti-CTLA-4 therapies or are ineligible for anti-CTLA-4 treatment. With an enrollment target of 400 patients, the trial will compare the combination therapy against other treatment options chosen by physicians. Key outcomes to be measured include overall survival, progression-free survival, and objective response rate. This study represents an important milestone for advancing new treatment opportunities in melanoma, a common cancer with a high rate of new cases and deaths, particularly for patients who have exhausted standard immune checkpoint therapies.
Read Announcement
RP1 + Opdivo (nivolumab) - (IGNYTE) FDA Regulatory Timeline and Events
RP1 + Opdivo (nivolumab) - (IGNYTE) is a drug developed by Replimune Group for the following indication: Melanoma / NSCLC.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- RP1 + Opdivo (nivolumab) - (IGNYTE)
- Announced Date:
- September 15, 2024
- Indication:
- Melanoma / NSCLC
Announcement
Replimune Group, Inc announced that data from the primary analysis of the IGNYTE clinical trial of RP1 combined with nivolumab were presented by Caroline Robert, M.D., Ph.D. of Gustave Roussy as a late breaking abstract during an oral session at the European Society for Medical Oncology (ESMO) Congress 2024 in Barcelona..
AI Summary
Replimune Group, Inc. recently announced encouraging results from the primary analysis of its IGNYTE clinical trial, which evaluated RP1 in combination with nivolumab. Caroline Robert, M.D., Ph.D. of Gustave Roussy presented the data as a late breaking abstract during an oral session at the European Society for Medical Oncology (ESMO) Congress 2024 in Barcelona. The trial showed that the combination therapy produced clinically meaningful anti-tumor activity across all subgroups, including patients who had prior treatments with anti-PD1 and anti-CTLA-4 therapies or had shown primary resistance to anti-PD1. Both injected and non-injected lesions responded similarly, indicating a strong systemic effect.
The promising findings, which include durable tumor response and a manageable safety profile, support further development. These results will underpin Replimune’s upcoming regulatory submission, aiming to offer a new treatment option for patients with anti-PD1 failed melanoma.
Read Announcement- Drug:
- RP1 + Opdivo (nivolumab) - (IGNYTE)
- Announced Date:
- August 22, 2024
- Indication:
- Melanoma / NSCLC
Announcement
Replimune Group, Inc. announced that a late-breaking abstract presenting the primary analysis of the IGNYTE clinical trial has been selected for oral presentation at the European Society for Medical Oncology (ESMO) Congress 2024 being held September 13-17, 2024, in Barcelona.
AI Summary
Replimune Group, Inc. announced that a late-breaking abstract from the IGNYTE clinical trial has been chosen for an oral presentation at the European Society for Medical Oncology (ESMO) Congress 2024. The congress will be held in Barcelona from September 13-17, 2024.
The abstract, which presents the primary analysis of the IGNYTE trial, focuses on the safety, efficacy, and survival data for a group of melanoma patients who did not respond to anti-PD-1 therapies. The study combines Replimune's RP1 with nivolumab. The oral presentation is scheduled for Sunday, September 15, 2024, from 3:45 to 3:50 p.m. CEST, and will be part of a mini session on melanoma and other skin tumors, with Caroline Robert, MD, PhD, from Gustave Roussy Cancer Center, set to speak.
Read Announcement- Drug:
- RP1 + Opdivo (nivolumab) - (IGNYTE)
- Announced Date:
- June 6, 2024
- Indication:
- Melanoma / NSCLC
Announcement
Replimune Group, Inc announced the topline results from the primary analysis of the IGNYTE clinical trial of RP1 plus nivolumab in anti-PD1 failed melanoma. .
AI Summary
Replimune Group, Inc. recently announced positive topline results from the primary analysis of the IGNYTE clinical trial. In this study, the combination of RP1 and nivolumab was tested in patients with anti-PD1 failed melanoma. Independent central review showed a 12-month overall response rate of 33.6%. All patients who responded had maintained their responses for more than six months, with a median duration exceeding 35 months, indicating durable outcomes in this difficult-to-treat group.
The trial involved 140 patients whose melanoma had progressed despite at least eight weeks of prior anti-PD1 therapy. Following these promising results, Replimune plans to submit a Biologics License Application in the second half of 2024 and expects to enroll the first patient in a confirmatory IGNYTE-3 trial in the third quarter of 2024. The company also highlighted the favorable safety profile of this treatment approach.
Read Announcement
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