Kimmtrak tebentafusp

Drug Class

Bispecific gp100 peptide-HLA-directed TCR-CD3 T-cell engager

Mechanism

Redirects CD3-positive T cells to target and kill uveal melanoma cells expressing the gp100 tumor-associated antigen.

Approved Indication

HLA-A*02:01-positive patients with unresectable or metastatic uveal melanoma, per its FDA approval.

What This Means For Patients

Kimmtrak is not distributed through mainland China's retail pharmacy network. Uwell Cloud can help arrange a purchase channel for this medicine, sourced and dispatched from Hong Kong; clinical administration support in China can be coordinated on request. Availability and eligibility for any specific patient are determined by clinical review.

Regulatory Approvals

• FDA — Approved (2022) — Sources

Pivotal Clinical Evidence

• IMCgp100-202 — Nathan et al., N Engl J Med 2021 (NCT03070392) — Sources

Sources

• https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-tebentafusp-tebn-unresectable-or-metastatic-uveal-melanoma
• https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761228s000lbl.pdf