Immunocore Holdings PLC on Tuesday said U.S. and European regulators will review on an expedited basis the biotechnology company's tebentafusp for the treatment of HLA-A*02:01-positive adults with metastatic uveal melanoma.
The Oxfordshire, U.K., company said the U.S. Food and Drug Administration granted priority review to its application, with a target action date of Feb. 23.
The FDA grants priority review to medicines that have the potential to provide significant improvements in the treatment of a serious disease, and the designation shortens the review period.
Immunocore said the European Medicines Agency's Committee for Medicinal Products for Human Use has agreed to the company's request for accelerated assessment of its application.
Immunocore said its applications are based on a Phase 3 study in which tebentafusp showed a clinically and statistically significant superior overall-survival benefit as a monotherapy in previously untreated metastatic uveal melanoma, the most common primary intraocular cancer in adults.
No comments:
Post a Comment
Note: Only a member of this blog may post a comment.