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While the guidance may lead to more streamlined CDx indications in precision oncology, test developers will still need to generate evidence, perhaps with limited pharma support.
A study of both tissue and blood samples from patients in a small trial found that liquid biopsy may detect putative resistance mutations missed in tissue.
A new analysis suggests hypermutation can occur in some chemotherapy-treated gliomas, producing heterogeneous, mutation-rich tumors with poor response to anti-PD-1 treatment.
The agency recognized that having some companion tests approved for a few but not all cancer drugs with the same molecularly defined indication is not optimal for patient care.
The first-in-class VT1021 would treat patients with various cancers whose tumors have high CD36 expression by reprogramming the tumor immune microenvironment.
Encorafenib (Pfizer/Array BioPharma's Braftovi) is approved in combination with cetuximab (Eli Lilly's Erbitux) for previously treated patients.
Oncolytics will run two biomarker validation studies before pursuing the first registration enabling trial in HR-positive, HER2-negative breast cancer for Reolysin.
Investigators reported on how ctDNA, measured using Natera's patient-specific Signatera assays, corresponded to a patient's disease progression and other biomarkers.
The team envisions developing an assay to guide targeted treatment for metastatic castration-resistant prostate cancer patients.
The FDA has granted priority review to the supplemental biologics license application for the second tissue-agnostic indication of Keytruda.