Vegzelma is a vascular endothelial growth factor inhibitor.
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The approvals were based on data from the LIBRETTO-001 trial.
The accelerated approval was based on data from the phase 2 DESTINY-Lung02 trial that included adults with HER2-mutant metastatic NSCLC after 1 prior systemic therapy.
The full approval was based on data from an additional 63 adults with metastatic NSCLC with confirmed MET exon 14 skipping as well as 22 months of follow-up time.
The approval was based on data from 2 multicenter, single-arm, open-label trials that included patients with unresectable, recurrent or refractory ALK-positive IMT.
The phase 3 study compared tiragolumab plus atezolizumab with placebo plus atezolizumab in adults with PD-L1 high locally advanced, unresectable or metastatic NSCLC.
The sBLA was supported by data from the phase 3 TOPAZ-1 trial.
The sBLA is supported by data from the phase 2 DESTINY-Lung01 trial, along with a phase 1 trial published in Cancer Discovery.
The approval was based on data demonstrating that the biosimilar product and the reference product were highly similar, and that there were no clinically meaningful differences between the agents.
Tiragolumab is a monoclonal antibody that works by binding to TIGIT, a protein receptor on immune cells, and suppresses the immune response to cancer.