FDA and EMA accept filings for tebentafusp in metastatic uveal melanoma

UK-based T cell receptor (TCR) biotech firm Immunocore (Nasdaq: IMCR) yesterday announced that regulators in the USA and European Union have each accepted applications for the approval of tebentafusp (IMCgp100) for the treatment of HLA-A*02:01-positive adult patients with metastatic uveal melanoma (mUM), with the news sending the firm’s US-traded shares up 8.4% to $31.49 by close of business.

The US Food and Drug Administration has accepted for review Immunocore’s Biologics License application (BLA) for tebentafusp (IMCgp100). The FDA has granted Priority Review to the submission, a designation for drugs which, if approved, may provide significant improvements in the safety and effectiveness of the treatment of serious conditions. Priority Review designation shortens the review period from the standard ten months to six months from the filing acceptance of the BLA, and therefore, an expected PDUFA target action date of February 23, 2022.

The BLA was initiated and will be reviewed under the Real-Time Oncology Review (RTOR) pilot program, an initiative of the FDA's Oncology Center of Excellence which is designed to expedite the delivery of safe and effective cancer treatments to patients. Tebentafusp is also being reviewed under the FDA’s Project Orbis initiative, which enables concurrent review by the health authorities in partner countries that have requested participation. Previously, the FDA has granted Breakthrough Therapy Designation (BTD) to tebentafusp for the treatment of HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma.