The FDA has approved the supplemental Biologics License Application (sBLA) for Keytruda® (Merck) to include an additional recommended dosage of 400mg every 6 weeks across all adult indications.
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 Food and Drug Administration (FDA) has approved Keytruda (pembrolizumab; Merck) for the treatment of patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer with carcinoma in situ (CIS) with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy.
Progression-free survival longer in those receiving tivozanib as third- or fourth-line therapy
Padcev is a first-in-class antibody-drug conjugate (ADC) directed against Nectin-4, an adhesion protein located on the surface of cells.
N-803 is an IL-15 superagonist complex consisting of an IL-15 mutant bound to an IL-15 receptor α/IgG1 Fc fusion protein
FDA label change linked to decrease in immunotherapy use, increases in chemotherapy use, PD-L1 testing
An Independent Data Monitoring Committee has recommended that SillaJen discontinue their phase 3 trial of Pexa-Vec (formerly JX-594) in patients with advanced hepatocellular carcinoma (HCC) following the evaluation of results from a formal pre-planned futility analysis.
Acelarin (NUC-1031; NuCana) has been granted Orphan Drug designation by the FDA for the treatment of biliary tract cancer.
The Food and Drug Administration has approved Bavencio (avelumab; EMD Serono), a programmed death-ligand 1 (PD-L1) blocking antibody, in combination with Inlyta (axitinib; Pfizer), a kinase inhibitor, for the first-line treatment of patients with advanced renal cell carcinoma (RCC).
