Replimune's RP1 Receives FDA Breakthrough Therapy Designation for Advanced Melanoma
Key Insights
Replimune's RP1 (vusolimogene oderparepvec) has been granted Breakthrough Therapy designation by the FDA for advanced melanoma (search) treatment.
The BLA for RP1 in combination with nivolumab has been submitted to the FDA under the Accelerated Approval pathway.
The designation is based on clinical activity observed in the IGNYTE clinical trial for patients who progressed on anti-PD1 (search) regimens.
Replimune Group Inc. has announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to RP1 (vusolimogene oderparepvec) in combination with nivolumab for the treatment of adult patients with advanced melanoma (search) who have previously received an anti-PD1 (search) containing regimen. The company has also submitted a Biologics License Application (BLA) to the FDA for RP1, seeking accelerated approval for the same indication.
The Breakthrough Therapy designation is intended to expedite the development and review of therapies for serious conditions where preliminary clinical evidence indicates that the drug may offer substantial improvement over available therapies on clinically significant endpoints. This designation was based on safety and clinical activity data from the anti-PD1 (search) failed melanoma (search) cohort of the IGNYTE clinical trial.
RP1 Mechanism of Action
RP1 is an oncolytic immunotherapy based on a proprietary strain of herpes simplex virus. It is engineered with a fusogenic protein (GALV-GP R-) and GM-CSF to maximize tumor cell killing, enhance the immunogenicity of tumor cell death, and activate a systemic anti-tumor immune response.
Ongoing Clinical Trial
The confirmatory Phase 3 IGNYTE-3 trial is currently enrolling patients. This trial evaluates RP1 in combination with nivolumab in advanced melanoma (search) patients who have progressed on anti-PD1 (search) and anti-CTLA-4 therapy, or who are not candidates for anti-CTLA-4 treatment.
Executive Perspective
"Today is an important milestone for Replimune and for the melanoma (search) community as we are one step closer to having another potential treatment available for patients who have limited options after progressing on anti-PD1 (search) containing regimens," said Sushil Patel, Ph.D., CEO of Replimune.