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The CHMP opinion is based on data from a Phase I/II study of dostarlimab in mismatch repair-deficient or microsatellite instability-high endometrial cancer.
News items for the week of Feb. 22, 2021.
Novartis plans to develop tislelizumab in combination with other agents in its pipeline and will commercialize the drug if it garners approval in these regions.
There is a dearth of standardized criteria for biomarker testing quality and access across the region, according to the report.
Kronos is working with Tempus to sequence patients' tumor samples in the study for MYC amplification and overexpression.
The firm said it will use the proceeds for working capital and general corporate expenses, including funding R&D and clinical trials, and business development.
The drugmaker will use Tempus' platform to validate the ability of its WEE1 inhibitor, ZN-c3, to inhibit DNA repair pathways in genetically defined cancers.
Lymphoma researchers in France and Belgium will conduct the Phase II trial of Daiichi Sankyo's investigational anti-EZH1/2 agent in five lymphoma subtypes.
The funding will advance Vividion's drug discovery platform and pipeline of therapeutics targeting NRF2-mutant and NRF2-addicted cancers.
The partners will develop a test to identify women most likely to benefit from VGX-3100, Inovio's immunotherapy to treat HPV-associated advanced cervical dysplasia.
Laboratory staffing and supply shortages limited patient access to cancer screening tests, and the pandemic decreased the development and validation of new tests.
The Epidemiology of Young Lung Cancer study will build on a prior genomics study to better characterize NSCLC patients diagnosed before age 40.
Day One will begin a Phase I/II trial this year of pimasertib and its pan-RAF kinase inhibitor, DAY101, in solid tumors with MAPK pathway aberrations.
The partners will research the ability of Biocept's Target Selector molecular assay to determine EGFR status in non-small cell lung cancer patients.
The Chinese company will use the funds to accelerate the registration and commercialization of its NGS-based products for cancer screening and early detection.
PreludeDx's DCISionRT test is for women diagnosed with ductal carcinoma in situ or stage 0 breast cancer who are treated with breast-conserving surgery.
The researchers found new molecular pathways of resistance, including hypoxia tolerance, protein folding, and mitochondria respiration.
Advanced NSCLC patients must have a PD-L1 expression tumor proportion score of 50 percent, and no EGFR, ALK, or ROS1 alterations, to receive the drug.
The company will use the funding to begin a Phase II/III clinical trial of its gamma secretase inhibitor, AL102, in desmoid tumors this year.
The UK's Medicines and Healthcare products Regulatory Agency approved the agent together with trastuzumab and chemo based on the Phase II HER2CLIMB trial.
The test, developed at George Mason, measures HER2 activation in a breast cancer biopsy to help determine if a patient will respond to treatment.
Researchers reclassified 86 percent of variants initially determined to be VUS, potentially changing surveillance or treatment approaches for patients.
News items for the week of Feb. 15, 2021.
The FDA also granted tebentafusp breakthrough therapy designation to treat patients with metastatic uveal melanoma.
The companies have worked together on a number of other cancer-related projects, including a companion diagnostic for the ovarian cancer treatment olaparib.