Kura Oncology said that it intends to enroll more patients for a registration-directed Phase II trial in 2020 following positive FDA feedback.
The companies had agreed in early 2018 to collaborate on the development of technologies to support precision oncology initiatives, but Roche said "priorities" have changed.
Olaparib is the first PARP inhibitor approved in China for first-line maintenance treatment of germline and somatic BRCA mutated gynecological cancers.
The approval is based on a Phase III trial showing that Tecentriq significantly improved survival in patients with metastatic non-small cell lung cancer.
The LCD will provide coverage for the Decipher Prostate Biopsy genomic test for men with both favorable and unfavorable intermediate-risk prostate cancer.
The companies aim to develop technologies for interpreting cancer genome data, with a focus on linking genetic profiles with treatment responses.
This is the first anti-PD-1 drug approved for front-line treatment of advanced and unresectable, recurrent head and neck cancer in the EU.
Doctors can now order the test to identify breast cancer patients with BRCA1/2 mutations who may be eligible for surgery or targeted therapy.
Recent studies question the clinical utility of tumor mutational burden as a biomarker for immuno-oncology response, and the FDA clearance includes no therapeutic indications.
The extended deal covers multiple blood cancer and solid tumor indications and will leverage several HalioDx technologies and approaches.
Roche noted that it expects the European Commission to approve trastuzumab emtansine in the near future, based on the EMA committee's recommendation.
The approval of its Omics Core assay for tumor-normal mutational profiling opens the door for payor reimbursement, which is key to reaching profitability, NantHealth said.
The firms will codevelop companion diagnostics for anti-PD1/PD-L1 immunotherapy treatments for cancer.
Promega's microsatellite instability technology will be used to develop an on-label, solid tumor companion diagnostic for pembrolizumab.
The drug has shown in clinical trials to improve outcomes in patients with FLT3 internal tandem duplication and tyrosine kinase domain mutations.
The company released new data showing that Cologuard 2.0 can detect colorectal cancer with higher sensitivity than the current version of the test.
CMS has attempted to address stakeholders' concerns about its coverage criteria for germline NGS testing in a new proposed national policy.
For heavily pretreated ovarian cancer patients, doctors will now have to weigh their HRD status in the context of an increasingly complex backdrop of biomarker information.
The vaccine targets multiple proteins that are overexpressed by breast tumors and aims to prevent the disease from developing.
The drug is now approved as a fourth-line option for advanced, fallopian tube, or primary peritoneal cancer patients who have homologous recombination deficiency.