Replimune's RP1 Gains Breakthrough Status and Files FDA Application for Accelerated Approval
Replimune Group, Inc. (NASDAQ: REPL), a biotechnology firm in the clinical phase, is at the forefront of creating innovative oncolytic immunotherapies. The company revealed that it has filed a biologics license application (BLA) with the FDA for the use of RP1 (vusolimogene oderparepvec) alongside nivolumab to treat adult patients suffering from advanced melanoma who have undergone prior treatment involving an anti-PD1 regimen. This application was submitted through the Accelerated Approval program. Additionally, Replimune disclosed that the FDA has awarded Breakthrough Therapy designation to RP1 in conjunction with nivolumab for this indication.
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The Breakthrough Therapy designation aims to accelerate the development and assessment of treatments for severe diseases when initial clinical data suggests that these treatments may significantly outperform existing options on one or more critical clinical endpoints. This designation stems from the safety and clinical efficacy observed in the anti-PD1 refractory melanoma group of the IGNYTE clinical trial.
“Today marks a significant achievement for Replimune and the melanoma community as we edge closer to offering another potential option for patients with limited alternatives following failure of anti-PD1 therapies,” stated Sushil Patel, Ph.D., the CEO of Replimune.
Currently, the confirmatory Phase 3 IGNYTE-3 trial is enrolling participants to evaluate RP1 in conjunction with nivolumab for advanced melanoma patients who have not responded to anti-PD1 and anti-CTLA-4 treatments, or who are ineligible for anti-CTLA-4 therapy.
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According to the data provided by the Synapse Chemical, As of November 27, 2024, there are 2 investigational drugs for the CSF-2R x GALV-GP R- target, including 8 indications, 2 R&D institutions involved, with related clinical trials reaching 12, and 1 patent.
Vusolimogene oderparepvec is an oncolytic virus drug that targets CSF-2R x GALV-GP R-. It is designed to treat a variety of therapeutic areas including neoplasms, skin and musculoskeletal diseases, and respiratory diseases. The drug is currently indicated for the treatment of melanoma, cutaneous squamous cell carcinoma, microsatellite instability-high cancer, and non-small cell lung cancer.
