Immunocore Announces UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) Accepts Marketing Authorization Application for Tebentafusp in Metastatic Uveal Melanoma
MHRA’s acceptance follows acceptances by the U.S. Food and Drug Administration and European Medicines Agency of Biologics License Application and Marketing Authorisation Application respectively for Tebentafusp in Metastatic Uveal Melanoma
Tebentafusp application part of the FDA’s Project Orbis initiative in the UK
(OXFORDSHIRE, England & CONSHOHOCKEN, Penn. & ROCKVILLE, Md., US, 8 September 2021) Immunocore (Nasdaq: IMCR), a late-stage biotechnology company pioneering the development of a novel class of T cell receptor (TCR) bispecific immunotherapies designed to treat a broad range of diseases, including cancer, infectious and autoimmune disease, today announces that United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) has accepted a Market Authorisation Application (MAA) seeking the approval of tebentafusp (IMCgp100) for the treatment of patients with metastatic uveal melanoma (mUM).
Tebentafusp is also being reviewed in the UK under the U.S. Food and Drug Administration’s (FDA) Project Orbis initiative, which enables concurrent review by the health authorities in participating partner countries. As previously announced, the FDA and European Medicines Agency have accepted the Biologics License Application (BLA) and MAA respectively for tebentafusp. In the United States, the BLA was initiated and will be reviewed under the Real-Time Oncology Review (RTOR) pilot program.