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.
Pfizer announced the launch of 3 new biosimilars: Zirabev (bevacizumab-bvzr), Ruxience (rituximab-pvvr) and Trazimera (trastuzumab-qyyp). Zirabev, a biosimilar to Avastin (bevacizumab; Genentech), is available for the treatment of 5 types of cancer: metastatic colorectal cancer; unresectable, locally advanced, recurrent or metastatic non-squamous non-small cell lung cancer; recurrent glioblastoma; metastatic renal cell carcinoma; and persistent, recurrent…
The FDA has approved Zirabev (bevacizumab-bvzr; Pfizer), a biosimilar to Avastin (bevacizumab; Genentech).
The Food and Drug Administration (FDA) has recommended that ImmunoGen, Inc. conduct a new phase 3 randomized trial to evaluate the safety and efficacy of mirvetuximab soravtansine (IMGN853) in patients with high folate receptor alpha (FRα)-positive, platinum-resistant ovarian cancer.