Replimune Group (REPL) FDA announcement summary

Introduction and purpose

• FDA granted accelerated approval for TUDRIQEV (vusolimogene oderparepvec-wtpg) in combination with nivolumab for adults with unresectable advanced cutaneous melanoma after progression on PD-1 or anti-PD-1 therapy.

• TUDRIQEV is the first approved product validating the RPx platform and represents the first oncolytic viral combination therapy to drive immune activation in this setting.

• Approval addresses a high unmet need in advanced melanoma, where current options are limited and prognosis is poor.

Details of approval or decision

• Approval is based on objective response rate and duration of response from the IGNYTE study; continued approval may depend on confirmatory trial results.

• TUDRIQEV is indicated for use with nivolumab in adults who progressed on PD-1 antibody-based regimens and is approved for a broad patient population, including those with superficial, deep, and visceral lesions, without requiring prior BRAF treatment.

Impact on industry and stakeholders

• TUDRIQEV addresses an estimated 10,000 addressable patients annually in the US who progress on PD-1 regimens.

• Broad label allows use in BRAF-naïve, pretreated, and adjuvant-relapsed patients.

• Launch strategy targets rapid adoption through early adopter accounts and extensive payer engagement, aiming for broad coverage and seamless patient access.

• Patient support program ReplimuneConnect Plus offers access, reimbursement, and financial support, assisting with enrollment and insurance navigation.