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The Phase I trial evaluated the safety and maximum tolerated dose of BAY-1895344 along with objective response rate among patients with DDR deficiencies.
The ulixertinib program is open to adult and adolescent cancer patients who have exhausted other treatment options and who have MAPK pathway alterations.
Sema4 will use its genomics testing abilities and Centrellis health intelligence platform to identify eligible patients for Janssen's oncology clinical trials.
The Swiss company will assess the agent both alone and combined with Tecentriq as a treatment for FGFR-positive gastric cancer.
In Europe, Blueprint will commercialize the drug first in Germany as a treatment for advanced GIST patients with a PDGFRA D842V mutation.
The firm said that adjuvant nivolumab had benefitted patients regardless of PD-L1 expression, and that the company will submit the data to regulatory agencies.
The company will seek FDA approval in advanced systemic mastocytosis, a disorder that can turn into cancer in 7 percent of children and 30 percent of adults.
The submission follows a clinical validation study of the test that analyzed data from samples collected from 400 US and Canadian patients with advanced HR+ breast cancer.
Avapritinib is sold by Blueprint Medicines as Ayvakit for the treatment of adults with unresectable or metastatic GIST harboring a PDGFRA exon 18 mutation.
The draft LCD would cover the Signatera minimal residual disease test for several solid tumor types and indications, including immunotherapy response monitoring.
The randomized trial will assess the glutaminase inhibitor plus standard-of-care versus standard-of-care alone in patients with KEAP1- or NRF2-mutated tumors.
The companies will explore the IDE196 and Xalkori combination in solid tumors with GNAQ or GNA11 mutations, such as metastatic uveal melanoma.
The company hopes the collaboration will allow it to home in on a molecularly defined population of patients likely to benefit from its targeted agent LP-184.
The agency has granted priority review to Pfizer's sNDA application and is slated to issue a decision by January 2020.
The company will use the proceeds to advance its lead BRAF inhibitor, PLX-8394, and develop new precision drugs using its FACT platform.
Interim results from a study in the Netherlands suggest whole-genome sequencing can be done fast enough to uncover treatment targets in metastatic cancer patients.
The company, which has a pipeline of six oncology drug assets and an AI-based diagnostic platform, now hopes to reach patients in the US oncology market.
Promega will develop its microsatellite instability assay as a companion diagnostic for Incyte's anti-PD-1 drug candidate retifanlimab in endometrial cancer.
However, the ClarIDHy trial did meet the primary endpoint of progression-free survival, based on which the firm will submit the drug for FDA approval in Q1 2021.
The decision is based on data from the PAOLA-1 trial, which focused on patients with tumors that have homologous repair recombination deficiency.
CHMP recommended approval only in patients with BRCA1/2 mutations, while the FDA approved olaparib in those with mutations in additional HRR genes.
The deal, which was approved by the boards of directors of both companies, is expected to close in the second half of 2021, pending customary conditions.
An initial program aims at the development of a serum neurofilament light chain immunoassay to support Novartis' MS and other neuroscience programs.
After five years, nearly half the Lynparza-treated patients in the SOLO-1 trial remained disease-free, compared with one-fifth of those who received placebo.
The European Commission will now consider CHMP's opinion and decide whether to approve the regimen as a first-line option for metastatic NSCLC patients without EGFR or ALK alterations.