EMA Recommends Granting Market Authorization in EU for New Medicine for Rare Type of Eye Cancer

The European Medicines Agency (EMA) has recommended granting a marketing authorization in the European Union (EU) for Kimmtrak (tebentafusp), a monotherapy for the treatment of adult patients with uveal melanoma, a rare type of eye cancer.

Uveal melanoma is a rare and aggressive form of eye cancer where cancer cells form in the tissues of the eye. The cancer can resist treatments and spreads quickly through the body. Many patients survive less than a year after the cancer has spread. According to the EMA, uveal melanoma affects between 5 and 11 patients per million. Surgery, radiation therapy, and removal of the eye are currently the most widely used treatment options for non-metastatic uveal melanoma.

Tebentafusp is a bispecific fusion protein that helps the immune cells get close enough to the cancer cells to attack them. It can be used in adult patients who are human leukocyte antigen (HLA)-A*02:01-positive and have unresectable or metastatic uveal melanoma.

EMA’s Committee for Medicinal Products for Human Use recommended the medicine for marketing authorization under an accelerated timeline to enable faster patient access. The recommendation will be sent to the European Commission for a decision.

Source: EMA