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The company will discuss with the FDA the possibility of using these preliminary Phase I results as part of its registrational package for the agent.
The company presented on the preliminary activity of RMC-4630 combined with Cotellic and said it is studying the SHP2 inhibitor alongside an AstraZeneca drug.
The test analyzes substitutions, insertion and deletion alterations, and copy number alterations in 324 genes, along with some genomic signatures in solid tumors.
The company's aim in the Beat AML subprotocol is to determine the safety, maximum tolerated dose, and response rate with dubermatinib and chemotherapy.
Although pandemic-related manufacturing delays impacted the NDA filing, the company remains on track to file its PMA for the companion diagnostic by year end.
The agency made the recommendation based on data showing that Keytruda improved outcomes and was cost-effective compared to the standard treatment.
A case series in partnership with My Gene Counsel to highlight the challenges genetics professionals and oncologists are grappling with as genetic testing is increasingly used in patient care.
The Broad Institute's CRISPR paralog screening platform will inform Ideaya's synthetic lethality-based target and biomarker discoveries.
BridgeBio will fund research at the Salk Cancer Center over three years with the goal of developing new drugs based on the institute's research.
The study will assess the safety and anti-tumor activity of the IL-7 agent and the checkpoint inhibitor combination for patients with PD-L1-expressing NSCLC.
The Prostate Cancer Biomarker Enrichment and Treatment Selection Study will match patients to treatments based on liquid biopsy-based biomarker evaluation.
The drug firm expects to begin a Phase I/II tumor-agnostic trial of the drug in genetically defined cancers in the second half of 2021.
The company submitted data from the ADAURA study, and the agency is slated to issue a decision on the application by the first quarter in 2021.
The multi-cohort brain cancer study will include Kazia's investigational drug in a new arm, which will start enrolling patients in early 2021.
The decision comes after EMA's CHMP determined that the submitted evidence was not strong enough to demonstrate the drug's benefit in this setting.
The agency issued a new draft decision memo, outlining various criteria it intends to apply when determining coverage for current and future blood-based CRC screening tests.
Using RNA and DNA sequencing to predict tumor site and detect gene alterations may allow patients with CUP to receive appropriate targeted treatment.
The NCCN's research program will put out a request for proposals early next year for studies to investigate neratinib in various molecularly defined cancers.
The aggressive subtype, uncovered by a team of researchers in Germany, may also be susceptible to targeted therapy that blocks interferon signaling.
Myriad Genetics' EndoPredict, Agendia's MammaPrint (distributed in Germany by PathoNext), and Veracyte's Prosigna will now be covered by public insurance.
The Phase Ib trial assessed the bespoke cancer vaccine NEO-PV-01 plus Opdivo as a treatment for patients with advanced melanoma, NSCLC, and bladder cancer.
Researchers surveyed 171 physicians in the NCI-MATCH study to determine their tumor profiling practices and barriers to participation in future studies.
The partners will integrate CCPM's research biobank with personalized genomic information to develop and commercialize the saliva-based tests.
The company is studying lasofoxifene in combination with Eli Lilly's Verzenio in certain metastatic breast cancer patients with ESR1 mutations in their tumors.
A pooled analysis of clinical trials and real-world data shows that the anti-tumor activity of Boehringer Ingelheim's TKI is unaffected by patients' ethnicity.