NEW YORK – The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) on Friday issued a positive opinion for Immunocore's Kimmtrak (tebentafusp) for patients with HLA-A*02:01-positive unresectable or metastatic uveal melanoma.
The EMA will now review CHMP's opinion and decide whether to make the treatment available for patients in Europe in this setting. If approved, Oxfordshire, England-based Immunocore said Kimmtrak would be the first T-cell receptor treatment to reach the European market.
"This year, hundreds of people across the EU will be diagnosed with metastatic uveal melanoma," Immunocore CEO Bahija Jallal said in a statement. "Left with minimal-to-no options, these patients have a devastating prognosis."
A month earlier, the US Food and Drug Administration approved Kimmtrak for the same indication. Regulators in both the US and Europe reviewed data from a randomized Phase III trial, which showed that Kimmtrak significantly improved overall survival in previously untreated metastatic uveal melanoma patients compared to investigator's choice of treatment with Merck's Keytruda (pembrolizumab), Bristol Myers Squibb's Yervoy (ipilimumab), or dacarbazine.
"Kimmtrak is the first therapy to demonstrate a survival benefit in patients with this disease, providing new hope to these individuals and to the doctors treating them," Jallal added.
Immunocore said its regulatory submission for Kimmtrak has been accepted by the UK's Medicines and Healthcare Regulatory Agency, Health Canada, and the Australian Government Department of Health Therapeutic Goods Administration. The treatment is also available to metastatic uveal melanoma patients through a global early-access program the company launch in April 2021. More than 200 patients have garnered early access to the drug through this program.