'Breakthrough' status for Immunocore's tebentafusp

The US Food and Drug Administration has granted coveted Breakthrough Therapy designation (BTD) to tebentafusp (IMCgp100) for the treatment of HLA-A 02:01-positive adult patients with unresectable or metastatic uveal melanoma (mUM), a common and hard-to-treat form of eye cancer.

Tebentafusp is the lead product candidate of UK-based T cell receptor (TCR) biotech firm Immunocore (Nasdaq: IMCR), whose shares were up 6.8% at $48.00 in pre-market trading this morning.

Immunocore’s chief executive, Bahija Jallal, commented: “We are delighted that the FDA has granted Breakthrough Therapy Designation for tebentafusp based on the survival benefit from our Phase III clinical trial announced in November 2020. There is an urgent need for an approved treatment for this rare and aggressive form of melanoma and we look forward to continuing to work with regulators to bring tebentafusp to patients as quickly as possible.”