FDA Accepts Biologics License Application for Tebentafusp in Metastatic Uveal Melanoma

The FDA and European Medicines Agency have approved a biologics license application (BLA) and marketing authorization application for tebentafusp (IMCgp100) in the treatment of patients with HLA-A*02:01–positive metastatic uveal melanoma, according to a press release from agent’s developer, Immunocore Holdings.1

The submissions are based on findings from the phase 3 IMCgp100-202 trial (NCT03070392), which evaluated tebentafusp in a population of patients with previously untreated metastatic uveal melanoma.2 Data from the study, which were presented at the 2021 American Association for Cancer Research Annual Meeting, indicated that after a median follow up of 14.1 months, patients treated with the experimental agent experienced a median overall survival (OS) of 21.7 months (95% CI, 18.6-23.6) compared with investigator’s choice of pembrolizumab (Keytruda), ipilimumab (Yervoy), or dacarbazine at 16.0 months (95% CI, 9.7-19.4; stratified HR, 0.51; 95% CI, 0.37-0.71; P <.0001). Moreover, the 1-year OS rate was 73.2% in the tebentafusp arm vs 58.5% in the control arm.

The priority review designation for the novel T-cell receptor bispecific immunotherapy agent could shorten the review period from a standard 10 months to 6 months from the filing acceptance. As such, the anticipated Prescription Drug User Fee Act date is February 23, 2022.

The BLA is currently being reviewed under the Real-Time Oncology pilot program, which is designed to expedite the delivery of tolerable and efficacious treatments for patients with cancer. Tebentafusp is also being assessed by the FDA’s Orbis initiative, which allows for concurrent review by health authorities in partner countries. Previously, the FDA had granted tebentafusp a breakthrough therapy designation as a treatment for adult patients with HLA-A*02:01–positive unresectable or metastatic uveal melanoma.

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