European Commission
AbbVie's Elahere Approved in Europe for FRα-Positive Ovarian Cancer
Elahere's companion diagnostic, Roche's Ventana FOLR1 (FOLR1-2.1) RxDx assay, also garnered CE marking.
EMA's CHMP Recommends Approval for First-Line Opdivo-Yervoy in Certain Colorectal Cancers
Patients with MSI-high/dMMR advanced colorectal cancers had a 79 percent lower risk of disease progression or death on Opdivo-Yervoy compared to chemo.
Astellas' Vyloy Approved in Europe as First-Line Treatment for CLDN18.2-Positive Gastric Cancer
The European Commission approval was based on two Phase III trials showing Vyloy plus chemo improved survival outcomes versus chemo alone.
Braftovi, Mektovi Approved in Europe for BRAF V600E-Mutant NSCLC
A Phase II trial of the combo demonstrated response rates of 75 percent and 46 percent in treatment-naïve and previously treated NSCLC patients, respectively.
J&J's Balversa Approved in Europe for FGFR3-Mutant Bladder Cancer
The approval was based on results from the Phase III THOR study, which compared Balversa to chemotherapy.