Immunocore's Eye Cancer Candidate Under Priority Review In US, Europe

The U.S. and European Union regulators have accepted for review Immunocore Holdings Plc's IMCR marketing applications seeking approval for tebentafusp for uveal melanoma (eye cancer).
Related: Newly Listed Immunocore's Tebentafusp Receives Breakthrough Therapy Tag For Eye Cancer.
The Company filed for HLA-A*02:01-positive adult patients with metastatic uveal melanoma (mUM).
The FDA has granted Priority Review for tebentafusp application with an expected PDUFA target action date of February 23, 2022.
The EMA has agreed to the Company's request for accelerated assessment of the application, reducing the timeframe for review to 150 days from 210 days.
The regulatory submissions are based on data from the Phase 3 trial. In the final trial analysis, tebentafusp demonstrated clinically and statistically significant superior overall survival (OS) benefit as a monotherapy.
The primary endpoint was achieved with the OS Hazard Ratio (HR) in the intent-to-treat population favoring tebentafusp, HR=0.51 over investigator's choice (82% pembrolizumab; 12% ipilimumab; 6% dacarbazine).
Related content: Benzinga's Full FDA Calendar
Price Action: IMCR shares are up 7.40% at $31.20 during the premarket session on the last check Tuesday.