The FDA’s recent greenlight of a new Keytruda indication gives a large group of patients with melanoma access to a treatment option that they didn’t previously have, says an expert from the UPMC Hillman Cancer Center.
Regulatory
FDA grants priority review to tebentafusp for metastatic uveal melanoma
Tebentafusp-tebn (Kimmtrak, Immunocore) — the only FDA-approved treatment for this indication — is the first T-cell receptor therapeutic to receive regulatory approval.
FDA Approves Tebentafusp-tebn for Unresectable or Metastatic Uveal Melanoma
The FDA has approved tebentafusp-tebn (Kimmtrak) for the treatment of HLA-A*02:01–positive adult patients with unresectable or metastatic uveal melanoma.
FDA grants fast track designation to BNT111 for advanced melanoma
BNT111 (BioNTech) — an investigational cancer immunotherapy — uses a fixed combination of mRNA-encoded, tumor-associated antigens designed to activate a precise and strong immune response against cancer.