phase II clinical study
FDA Approves Takeda's Exkivity With Thermo Fisher CDx for EGFR Exon20 Insertion-Positive NSCLC
This is the first time the FDA has approved a drug specifically for NSCLC patients who harbor rare EGFR Exon20 insertion mutations.
FDA Approves GlaxoSmithKline's Jemperli, Roche’s Ventana CDx for dMMR Solid Cancers
The approval expands the label for GSK's anti-PD-1 agent dostarlimab, which the FDA initially approved in April for patients with dMMR endometrial cancers.
Burning Rock Biotech, Impact Therapeutics Partner on CDx for PARP Inhibitor Senaparib
The NGS firm will work with Impact to develop companion diagnostics to select patients eligible for Impact's synthetic lethality drugs, beginning with senaparib.
NeoGenomics, Elevation Oncology Partner on NRG1 Fusion Testing for Clinical Trial Enrollment
NeoGenomics will use its gene fusion panels to identify patients with solid tumors and an NRG1 fusion who might qualify for Elevation's Phase II CRESTONE study.Â
Natera Molecular Residual Disease Test to be Used in Breast Cancer Trial of Ibrance
The randomized, Phase II trial will test ctDNA-guided second-line adjuvant therapy for stage II and III hormone receptor-positive, HER-2 negative breast cancer.