Immunocore : FDA Approves Kimmtrak To Treat Unresectable Or Metastatic Uveal Melanoma

(RTTNews) - Immunocore Holdings plc (IMCR) said Wednesday that the United States Food and Drug Administration approved Kimmtrak or tebentafusp-tebn for the treatment of HLA-A02:01-positive adult patients with unresectable or metastatic uveal melanoma.

The company expects to make the product commercially available in the United States within weeks.

Kimmtrak was granted Breakthrough Therapy Designation for unresectable or metastatic uveal melanoma by the FDA in February 2021. The approval was granted four weeks ahead of the assigned PDUFA date of February 23, 2022.

The European Medicines Agency, the United Kingdom's Medicines and Healthcare Regulatory Agency, Health Canada, and the Australian Government Department of Health Therapeutic Goods Administration have accepted the submission of the company's Marketing Authorisation Application.

Additionally, Immunocore launched a global early access program to make KIMMTRAK readily available to metastatic uveal melanoma patients. There are currently over 200 patients in 13 countries in the early access program.