Immunocore Announces that U.S. Food and Drug Administration and European Medicines Agency accept Biologics License Application and Marketing Authorization Application for Tebentafusp in Metastatic Uveal Melanoma
Excerpt from the Press Release:
(OXFORDSHIRE, England & CONSHOHOCKEN, Penn. & ROCKVILLE, Md., US, August 24, 2021) Immunocore Holdings Plc (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 regulators in the United States and European Union have each accepted applications for the approval of tebentafusp (IMCgp100) for the treatment of HLA-A*02:01-positive adult patients with metastatic uveal melanoma (mUM).
The U.S. Food and Drug Administration (FDA) has accepted for review Immunocore’s Biologics License application (BLA) for tebentafusp (IMCgp100). The FDA has granted Priority Review to the Company’s BLA submission, a designation for drugs which, if approved, may provide significant improvements in the safety and effectiveness of the treatment of serious conditions. Priority Review designation shortens the review period from the standard ten months to six months from the filing acceptance of the BLA, and therefore, an expected PDUFA target action date of February 23, 2022.
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