TUDRIQEV

STN: 125827
Proper Name: vusolimogene oderparepvec-wtpg
Trade Name: TUDRIQEV
Manufacturer: Replimune, Inc.
Indication:

A genetically modified oncolytic viral therapy indicated in combination with nivolumab for the treatment of adult patients with unresectable advanced cutaneous melanoma who experienced disease progression with a programmed death receptor-1 (PD-1)-blocking antibody-based regimen. This indication is approved under accelerated approval based on objective response rate (ORR) and duration of response. Continued approval for this indication may be contingent upon verification of clinical benefit in confirmatory trial(s).

Product Information

Package Insert - TUDRIQEV
Demographic Subgroup Information – vusolimogene oderparepvec-wtpg – TUDRIQEV
Refer to Section 1.1 of the clinical review memo for information about participation in the clinical trials and any analysis of demographic subgroup outcomes that is notable.