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.
The approval was based on data from the phase 3 KEYNOTE-826 trial.
Drugs in the Pipeline
Tisotumab vedotin is an investigational antibody-drug conjugate targeted to tissue factor.
The FDA has approved Keytruda (pembrolizumab; Merck), a programmed death receptor-1 -blocking antibody, as monotherapy for the first-line treatment of patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer.
The FDA has approved Tecentriq® in combination with Avastin® for the treatment of patients with unresectable or metastatic hepatocellular carcinoma who have not received prior systemic therapy.