Replimune Group (REPL) has upcoming FDA regulatory milestones for RP1 (vusolimogene oderparepvec). The table below outlines estimated target dates and event types for these pending regulatory actions.
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, 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: For the treatment of anti-PD1 failed 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:
- June 26, 2026
- Target Action Date:
- August 2, 2026
- Indication:
- In Advanced Melanoma
Announcement
Replimune Group, Inc. announced that The FDA considers this a complete, class 1 response with a goal date of August 2, 2026, and has notified the company to expect an advisory committee meeting in late July.
AI Summary
Replimune Group, Inc. said the FDA is treating its RP1 BLA resubmission as a complete, Class 1 response, with a target action date of August 2, 2026. The company also said the agency has told it to expect an advisory committee meeting in late July, which would give experts a chance to review the treatment’s safety and effectiveness before the FDA makes its final decision.
The resubmission asks for accelerated approval of RP1, also called vusolimogene oderparepvec, for advanced melanoma. The request is based on results from the IGNYTE trial, where RP1 was studied together with nivolumab in patients whose cancer had already progressed after treatment that included an anti-PD-1 drug. Replimune said it is looking forward to a scientific and clinical discussion about RP1’s risk and benefit in this hard-to-treat setting.
Read Announcement- Drug:
- RP1 (vusolimogene oderparepvec)
- Announced Date:
- June 26, 2026
- Indication:
- For the treatment of anti-PD1 failed melanoma
Announcement
Replimune Group, Inc announced today that the U.S. Food and Drug Administration (FDA) has accepted for review the resubmission of the Biologics License Application (BLA) for RP1 (vusolimogene oderparepvec) in combination with nivolumab for the treatment of advanced melanoma. .
AI Summary
Replimune Group said the U.S. Food and Drug Administration has accepted for review its resubmitted Biologics License Application for RP1, also called vusolimogene oderparepvec, when used with nivolumab for advanced melanoma. The company said this marks an important step toward possible accelerated approval for patients with a serious form of skin cancer who have limited treatment options.
According to Replimune, the request is based on results from the IGNYTE clinical trial, which studied RP1 plus nivolumab in patients whose disease had already gotten worse after an anti-PD-1 treatment. CEO Sushil Patel said the company is encouraged by the FDA’s quick review and looks forward to discussing RP1’s safety and benefit in this hard-to-treat setting.
Read Announcement- Drug:
- RP1 (vusolimogene oderparepvec)
- Announced Date:
- May 29, 2026
- Indication:
- In Advanced Melanoma
Announcement
Replimune Group, Inc. announced that following collaborative communications with the U.S. Food and Drug Administration (FDA), the Company and the FDA have aligned on a path forward for resubmission and reconsideration of the Biologics License Application (BLA) for RP1 (vusolimogene oderparepvec) in combination with nivolumab for the treatment of advanced melanoma.
AI Summary
Replimune Group said it and the U.S. Food and Drug Administration have agreed on a path forward for resubmitting and reviewing the Biologics License Application for RP1, also called vusolimogene oderparepvec, in combination with nivolumab for advanced melanoma. The company said the application is supported by results from the IGNYTE clinical trial, which studied patients whose disease had already gotten worse after treatment with an anti-PD-1 therapy.
Advanced melanoma remains a serious disease, with about 8,500 deaths each year in the U.S. Replimune said current checkpoint inhibitor treatments do not work well for about half of patients, showing the need for new options. RP1 is designed to kill tumor cells, boost the immune response against the tumor, and help the body fight cancer throughout the body.
Read Announcement- 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
- Target Action Date:
- H2 2024
- Estimated Target Date Range:
- July 1, 2024 - December 31, 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 nivolumab FDA Regulatory Timeline and Events
RP1 nivolumab is a drug developed by Replimune Group for the following indication: treatment of advanced melanoma in patients who progress on an anti-PD-1 containing regimen.
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 nivolumab
- Announced Date:
- May 30, 2026
- Indication:
- treatment of advanced melanoma in patients who progress on an anti-PD-1 containing regimen
Announcement
Replimune Group, Inc. , today presented 3-year landmark overall survival data from the IGNYTE clinical trial of RP1 plus nivolumab in patients with anti-PD-1 failed melanoma during an oral session at the 2026 American Society of Clinical Oncology annual meeting.
AI Summary
Replimune Group said new 3-year overall survival data from its IGNYTE clinical trial showed strong long-term results for RP1 plus nivolumab in patients with melanoma that had failed anti-PD-1 treatment. Nearly half of all treated patients were alive at three years, and survival was even higher among people who responded to the treatment, at 83.5%. The company said this suggests a durable benefit in a cancer setting where treatment options have historically been limited. The findings were presented during an oral session at the 2026 American Society of Clinical Oncology annual meeting. Replimune said the results support the potential of RP1, its lead product candidate, as part of an approach designed to help kill tumor cells and trigger a broader immune response against cancer.
Read Announcement- Drug:
- RP1 nivolumab
- Announced Date:
- November 7, 2025
- Indication:
- treatment of advanced melanoma in patients who progress on an anti-PD-1 containing regimen
Announcement
Replimune Group, Inc. announced that biomarker data and updated clinical data from the IGNYTE clinical trial of RP1 plus nivolumab was presented as a late-breaking abstract during an oral session at the 40th Annual Meeting of the Society for the Immunotherapy of Cancer (SITC 2025) in National Harbor, Maryland. Two additional posters on RP1 are also being presented.
AI Summary
Replimune announced that biomarker and updated clinical data from the IGNYTE trial of RP1 plus nivolumab were presented as a late‑breaking oral abstract at the 40th Annual Meeting of the Society for the Immunotherapy of Cancer (SITC 2025). Two additional posters on RP1 were also presented at the meeting.
The late‑breaking data showed that adding RP1 to nivolumab can reprogram the tumor microenvironment and reverse known resistance mechanisms to PD‑1 blockade. Treatment led to upregulation of gene signatures tied to PD‑1 responsiveness. With longer follow‑up (7 months), the combination produced an objective response rate (ORR) of 33.6% and a median duration of response of 24.8 months. Durability was consistent across PD‑L1 positive and negative tumors and in both primary and secondary resistance settings (PD‑L1 negative DOR 24.8 months; primary resistance DOR 22.6 months).
Additional posters reported comparable efficacy of RP1 plus nivolumab in BRAF‑mutant and wild‑type melanoma, with greater activity in BRAF‑naïve patients, and that extended RP1 retreatment beyond eight doses was well tolerated and beneficial for many patients.
Read Announcement- Drug:
- RP1 nivolumab
- Announced Date:
- October 20, 2025
- Target Action Date:
- April 10, 2026
- Indication:
- treatment of advanced melanoma in patients who progress on an anti-PD-1 containing regimen
Announcement
Replimune Group, Inc. announced that The PDUFA date set by the FDA is April 10, 2026 based on a Class II resubmission timeline.
AI Summary
Replimune Group, Inc. announced the FDA has accepted its BLA resubmission for RP1 combined with nivolumab. The agency set a PDUFA date of April 10, 2026 under a Class II resubmission timeline.
RP1 plus nivolumab is designed to treat advanced melanoma in patients who no longer respond to anti-PD-1 therapies. The combination aims to improve outcomes for a group with limited treatment options. Additional data and analyses were submitted to support this resubmission.
RP1 is an oncolytic immunotherapy based on a modified herpes virus armed with proteins to boost tumor killing and immune activation. It promotes both local tumor destruction and a systemic immune response.
CEO Sushil Patel said the team will work closely with the FDA to expedite review. If approved, the therapy could offer a new option for melanoma patients. Replimune is advancing its RPx platform in multiple cancer types.
Read Announcement- Drug:
- RP1 nivolumab
- Announced Date:
- October 20, 2025
- Indication:
- treatment of advanced melanoma in patients who progress on an anti-PD-1 containing regimen
Announcement
Replimune Group, Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted the resubmission of the Biologics License Application (BLA) for RP1 in combination with nivolumab for the treatment of advanced melanoma in patients who progress on an anti-PD-1 containing regimen.
AI Summary
Replimune announced that the U.S. Food and Drug Administration has accepted its resubmission of the Biologics License Application for RP1 combined with nivolumab to treat advanced melanoma in patients who no longer respond to anti–PD-1 therapy. The FDA set a target action date of April 10, 2026, under a standard review timeline.
Sushil Patel, Ph.D., CEO of Replimune, said the company is pleased with the acceptance. He noted that RP1 plus nivolumab offers a strong risk-benefit profile for patients with few available options. Patel added that Replimune will work closely with the FDA to help speed the review for the benefit of patients.
RP1 is Replimune’s lead therapy. It uses a modified herpes simplex virus armed with a fusogenic protein and GM-CSF. This design aims to increase tumor cell killing, boost the immune response, and improve treatment results when combined with other cancer 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:
- October 19, 2025
- Indication:
- Melanoma / NSCLC
Announcement
Replimune Group, Inc. announced data from a new ad hoc analysis from the IGNYTE phase 2 cohort of RP1 plus nivolumab was presented by Caroline Robert, M.D., Ph.D., at the European Society for Medical Oncology (ESMO) Congress 2025 being held in Berlin (Poster 1644P).
AI Summary
Replimune Group, Inc. announced an ad hoc analysis from the IGNYTE phase 2 trial of RP1 plus nivolumab, presented by Dr. Caroline Robert at the ESMO Congress 2025 in Berlin (Poster 1644P). The analysis focused on acral melanoma, a rare and aggressive form of skin cancer that often resists standard treatments.
Among 18 acral melanoma patients, the combination achieved an objective response rate of 44% and a median duration of response of 11.9 months. Most treatment-related adverse events were mild or moderate (grade 1–2) and resolved quickly, indicating a favorable safety profile.
The IGNYTE-3 phase 3 trial is now recruiting patients to compare RP1 plus nivolumab against physicians’ choice of therapy in melanoma that has progressed after anti-PD-1 and anti-CTLA-4 treatment. This study aims to confirm the potential of RP1 as a new option for hard-to-treat melanoma.
Read Announcement- Drug:
- RP1 + Opdivo (nivolumab) - (IGNYTE)
- Announced Date:
- September 2, 2025
- Indication:
- Melanoma / NSCLC
Announcement
Replimune Group, Inc. announced that a Type A meeting with the U.S. Food and Drug Administration (FDA) has been scheduled to discuss the complete response letter (CRL) for the Company's Biologics License Application (BLA) for RP1 in combination with nivolumab for the treatment of advanced melanoma.
AI Summary
Replimune Group, Inc. announced that the U.S. Food and Drug Administration has scheduled a Type A meeting to discuss the agency’s complete response letter for the Company’s Biologics License Application for RP1 in combination with nivolumab for advanced melanoma. This meeting will focus on the FDA’s feedback and help Replimune clarify outstanding questions about the data package supporting RP1’s safety and efficacy.
Replimune plans to present additional clinical information, proposed manufacturing details, and study design updates. Company leadership expects the discussion to outline clear steps toward resubmission and potential approval. The meeting represents a key milestone in the regulatory review process for RP1. Replimune will use the FDA’s feedback to refine its submission and plan future clinical trials, demonstrating its commitment to advancing oncolytic therapy for melanoma patients. Replimune aims to move swiftly through the review process to reach patients in need.
Read Announcement- 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
