Cancer patients with biomarker-positive tumors have better outcomes on immune checkpoint inhibitor therapy, a meta-analysis suggests.
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A regulatory decision is expected on November 27, 2023.
Improvement seen compared with chemotherapy alone for first-line treatment of advanced non-small cell lung cancer.
Amivantamab can provide a long-term benefit in NSCLC patients with EGFR exon 20 insertions whose disease progressed on platinum-based chemotherapy, a study suggests.
Keytruda is a programmed death receptor-1 (PD-1)-blocking antibody.
The designation is supported by data from the ongoing phase 2 KEYNOTE-942 study, which included 157 patients with stage III/IV melanoma following complete resection.
Eight of nine patients with major pathological response (MPR) were alive and disease-free at five years, while six of 11 without MPR experienced relapse
Despite NCCN guidelines recommending FDG PET/CT, 43.6 percent of patients were imaged with CT alone before subsequent radiation therapy
The approval was based on data from the KEYNOTE-091 trial.
The ready-to-dilute formulation was developed to eliminate the reconstitution step with Alimta.