The sBLA is supported by data from the phase 3 NRG-GY018 trial, which included patients with stage III-IV or recurrent endometrial carcinoma whose cancer was either pMMR or dMMR.
All articles by Brian Park, PharmD
Amtagvi is a tumor-derived autologous T cell immunotherapy designed to deploy patient-specific T cells called TIL cells to locate and attack cancer cells.
The application is supported by data from the phase 3 CheckMate -77T trial which included 452 treatment-naive patients with resectable stage IIA to IIIB NSCLC.
The sBLA submission was supported by data from the phase 2 DESTINY-PanTumor02 trial, which included adults with selected HER2-expressing tumors.
Coherus has launched the Loqtorzi Solutions program, which provides support services to prescribers and patients.
The sBLA is supported by data from the phase 3 KEYNOTE-A39 trial, which compared pembrolizumab plus enfortumab vedotin-ejfv to standard of care chemotherapy.
Tovorafenib is an oral, brain-penetrant, highly-selective type II RAF kinase inhibitor designed to target a key enzyme in the MAPK signaling pathway.
The approval was based on data from the phase 3 KEYNOTE-671 trial.
Opdivo is a programmed death receptor-1 (PD-1) blocking antibody.
Aphexda is expected to be available in September 2023.
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