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Atrin will use Predictive's GenDB databases and women's health biobank to study germline mutations in DNA damage and response inhibitor pathways.
The final national coverage decision stipulates that NGS germline tests for assessing hereditary breast and ovarian cancer risk must have FDA's blessing.
Myriad filed an sPMA for myChoice CDx despite GSK's confidence that Zejula will be approved in newly diagnosed ovarian cancer regardless of biomarker status.
Based on cost-effectiveness estimates and a lack of comparison against afatinib, NICE will recommend against using osimertinib for first-line treatment of NSCLC.
BBT-176, a novel agent designed to inhibit EGFR with C797S mutations, will start first-in-human studies in NSCLC this year.
AstraZeneca and Merck also announced they have filed for approval of Lynparza in patients who have mutations in more than a dozen homologous recombination repair genes.
Increasing understanding of complex tumor biology is reshaping clinical trials in the age of precision medicine, though some view these changes with concern.
Puma provided an update on its plan for Nerlynx and Natera discussed the cancer trials its Signatera test is being used in.
The FDA granted priority review status to rucaparib for prostate cancer patients with BRCA1/2 mutations.
Among the firms presenting, drugmakers, speciality biotechs, and genetic testing firms provided an update on their precision oncology development programs.
The companies will develop tissue-based companion diagnostics for Amgen's investigational treatment AMG 510 for non-small cell lung cancer.
Genentech will use Adaptive's ClonoSeq assay for MRD testing in a CLL study. Adaptive will receive upfront and sample testing payments of undisclosed amounts.
Insight's portfolio includes a gene expression-based immuno-oncology assay for therapy response prediction.
In the trial that led to Ayvakit's approval, 84 percent of patients with PDGFRA exon 18 mutations saw their tumors shrink.
The partners will focus on optimizing technology and conducting clinical utility studies for liquid biopsy and tissue-based genomic applications.
Despite the availability of more personalized options, the market dynamics are getting more complex and oncologists need education and tools to keep up with advances.
The approval will allow clinicians to identify NSCLC patients with ROS1 fusion genes who could benefit from treatment with Rozlytrek.
The drug is approved as a maintenance treatment for platinum-responsive metastatic pancreatic cancer patients with germline BRCA1/2 mutations.
Enhertu received accelerated approval based on data from a Phase II trial that reported a 60 percent overall response rate.
The drug is designed to tackle C797S resistance mutations that arise in NSCLC patients after treatment with third-generation tyrosine kinase inhibitors.