The draft guidance recommends access to the drug through the Cancer Drugs Fund as maintenance therapy of advanced ovarian, fallopian tube, or primary peritoneal cancer.
The recommendation is based on a study in which NSCLC patients without EGFR mutations or ALK rearrangements lived longer on the combo than just on chemo.
At a real-world data workshop, Wendy Rubinstein said that labs have a responsibility under the 21st Century Cures Act to facilitate integration of genomic data into EHRs.
The grant recipients will receive up to $5 million each and are led by scientists at institutions including Harvard Medical School and the Cleveland Clinic.
The software firm will use NGS data from patient biopsies to create molecular profiles and offer individualized cancer treatment recommendations.
Labs in China can now use the Cobas EGFR Mutation Test v2 with either tissue or plasma samples as a CDx for three Roche oncology drugs in NSCLC patients.
The firm has joined forces with AstraZeneca, the IASLC, and the Global Lung Cancer Coalition, with a goal to double five-year survival rates by 2025.
Based on the promising results, the company is advancing the tumor lysate, particle-loaded, dendritic cell vaccine into Phase III studies.
The study plans to recruit close to 300 patients with advanced non-small cell lung cancer, with half being treated based on liquid biopsy results.
The firm is using automated laboratory testing, artificial intelligence, and single-cell omics for a "precision" approach to cancer drug discovery.
Practical, technological, and systemic challenges are putting pathologists in tough positions, facing competing demands for molecular analysis of limited biological samples.
The DoD and VA-led initiative is moving beyond its initial focus on lung cancer to add analyses of multiple cancer types and a prospective, multisite study.
A Personalized Medicine Coalition-funded study has found that NGS-based testing is moderately cost effective but that access to targeted treatments remains a hurdle.
The firm also aims to commercialize a new version of its PraediCare Dx platform, which will directly detect heterodimer protein complexes on a tumor cell's surface.
In the 44-patient study, onvansertib will be studied in combination with Avastin and FOLFIRI in the second-line metastatic colorectal cancer setting.
An international team saw an overall survival benefit when using BRAF, MEK, and EGFR inhibitors together in previously treated, BRAF-mutated metastatic colorectal cancer patients.
A modified analogue of rucaparib is being used to track PARP-1 expression in PARP inhibitor-treated patients with pancreatic, breast, prostate, and other cancer types.
The partners are working together to advance tests that will identify which cancer patients have Notch activating mutations and fusions.
Novel clinical trials designs are enabling exploration of new precision oncology drug indications in Japan and China, and increasing patient access to treatments.
The FDA approved FoundationOne CDx as a companion diagnostic for olaparib for first-line maintenance therapy in BRCA-mutated advanced ovarian cancer.