New Medicines

Uveal melanoma - metastatic


New molecular entity

Development and Regulatory status

Pre-registration (Filed)
Pre-registration (Filed)
Pre-registration (Filed)
Sep 21MHRA accepts MAA [11].
Aug 21EMA accepts MAA for review under Accelerated Assessment Procedure. US FDA accepts BLA for tebentafusp in metastatic uveal melanoma for Priority Review with PDUFA target action date of 23/2/22 [10].
Feb 21US filings planned for Q3 2021, with EU filings shortly after [9].
Feb 21Granted breakthrough-therapy status in US [9].
Apr 19Also has Promising Innovative Medicine designation in the UK under UK Early Access to Medicines Scheme [5].
Apr 19Granted fast track designation in US [5]
Jan 16Has orphan drug status in US [4].
Sep 15Accepted on the EMA Adaptive Pathway pilot programme [4].


First-in-class bi-specific T cell redirector. It binds to a melanocyte-associated target peptide of gp100 presented on the surface of melanoma cells by Human Leukocyte Antigen molecules; once bound it redirects CD-3 positive T cells to kill cancer cells
Uveal melanoma (UM) is a serious life-threatening intraocular malignancy, primarily involving the choroid (90%), ciliary body (7%) or iris (2%). 98% of cases occur in Caucasians [1]. UM is the most common primary intraocular malignancy in adults, representing 3%–5% of all melanomas. Incidence varies by sex, race, and country. In Europe, incidence increases with latitude, ranging from 2 per million in Spain and Italy, 4-6 per million in Central Europe, and >8 per million in Denmark & Norway [2].
Uveal melanoma - metastatic
Intravenous infusion

Further information


Trial or other data

Sep 21MHRA accepts MAA [11].
Sep 21Results of PII RCT (NCT03070392) reported in NEJM [12].
Jan 21PII study (NCT03070392) is no longer recruiting and due to complete collection of primary outcome data in Sep 21 [8].
Nov 20PII trial IMCgp100-202 (NCT03070392) of tebentafusp vs. investigator choice in metastatic uveal melanoma (mUM) met the pre-defined boundaries for statistical significance of the primary endpoint of Overall Survival (OS) in its first pre-planned interim analysis conducted by the independent data monitoring committee [7].
Nov 19PII study (NCT03070392) is still recruiting; timescales unchanged [6].
Dec 18 PII study (NCT03070392) is still recruiting [3].
Oct 17PII study (NCT03070392) to evaluate the overall survival of HLA-A*0201 positive adult patients with previously untreated advanced UM receiving IMCgp100 compared to Investigator´s Choice of dacarbazine, ipilimumab, or pembrolizumab starts. 327 adults will be recruited from countries including the US & EU (plus UK). Collection of primary outcome data (OS) is due to complete Jul 20 [3].

Evidence based evaluations