FDA Flags Evidence Gaps in Replimune's RP1 Oncolytic Therapy for Skin Cancer

References

1. 1.Chen, E., & Herper, M. (2026, July 28). FDA staff reiterate concerns about Replimune skin cancer treatment. STAT News. https://www.statnews.com/2026/07/28/replimune-rp1-skin-cancer-fda-staff-analysis/
2. 2.Larkin, J., Chiarion-Sileni, V., Gonzalez, R., Grob, J. J., Rutkowski, P., Lao, C. D., Cowey, C. L., Schadendorf, D., Wagstaff, J., Dummer, R., Ferrucci, P. F., Smylie, M., Hogg, D., Hill, A., Marquez-Rodas, I., Haanen, J., Guidoboni, M., Maio, M., Schöffski, P., … Wolchok, J. D. (2019). Five-year survival with combined nivolumab and ipilimumab in advanced melanoma. New England Journal of Medicine, 381(16), 1535–1546. https://doi.org/10.1056/NEJMoa1910836
3. 3.Andtbacka, R. H. I., Kaufman, H. L., Collichio, F., Amatruda, T., Senzer, N., Chesney, J., Delman, K. A., Spitler, L. E., Puzanov, I., Agarwala, S. S., Milhem, M., Cranmer, L., Curti, B., Lewis, K., Ross, M., Guthrie, T., Linette, G. P., Daniels, G. A., Harrington, K., … Kaufman, H. L. (2015). Talimogene laherparepvec improves durable response rate in patients with advanced melanoma. Journal of Clinical Oncology, 33(25), 2780–2788. https://doi.org/10.1200/JCO.2014.58.3377
4. 4.Middleton, M. R., Devlin, M., Bhatt, M., Gupta, A., Sherrill, B., Ott, P. A., Chesney, J. A., Puzanov, I., Mehnert, J. M., Hauschild, A., Kirkwood, J. M., Agarwala, S. S., Tawbi, H. A., Cranmer, L. D., Gonzalez, R., Ferris, R. L., Saenger, Y. M., Ribas, A., Pavlick, A. C., … Kaufman, H. L. (2023). Phase 1 study of vusolimogene oderparepvec, an enhanced-potency oncolytic HSV-1, combined with atezolizumab in patients with solid tumours. Journal for ImmunoTherapy of Cancer, 11(1), e005412. https://doi.org/10.1136/jitc-2022-005412
5. 5.Beaver, J. A., Howie, L. J., Pelosof, L., Kim, T., Liu, J., Goldberg, K. B., Sridhara, R., Blumenthal, G. M., Farrell, A. T., Keegan, P., Pazdur, R., & Theoret, M. R. (2018). A 25-year experience of US Food and Drug Administration accelerated approval of malignant hematology and oncology drugs and biologics. JAMA Oncology, 4(6), 849–856. https://doi.org/10.1001/jamaoncol.2018.0570
6. 6.Kim, C., & Prasad, V. (2015). Cancer drugs approved on the basis of a surrogate end point and subsequent overall survival: An analysis of 5 years of US Food and Drug Administration approvals. JAMA Internal Medicine, 175(12), 1992–1994. https://doi.org/10.1001/jamainternmed.2015.5868
7. 7.Gyawali, B., Hey, S. P., & Kesselheim, A. S. (2021). Assessment of the clinical benefit of cancer drugs receiving accelerated approval. JAMA Internal Medicine, 181(10), 1390–1392. https://doi.org/10.1001/jamainternmed.2021.5985
8. 8.Harrington, K. J., Michielin, O., Malvehy, J., Pezzani Grüter, I., Grove, L., Frauchiger, A. L., & Dummer, R. (2021). A practical guide to the handling and administration of talimogene laherparepvec in Europe. OncoTargets and Therapy, 14, 1609–1628. https://doi.org/10.2147/OTT.S289184