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FDA clearance

The accelerated approval is based on results from two cohorts of a Phase II, single-arm trial in which EZH2-mutated patients had an overall response rate of 69 percent.

Clinicians will be able to use the assay to help identify patients with metastatic NSCLC for treatment with nivolumab and ipilimumab. 

RemeGen's anti-HER2 antibody drug conjugate disitamab vedotin already achieved an overall response rate of 60 percent in a Phase II trial conducted in China.

The firm said the FDA clearance was supported by data across several lab sites and all variant classes in clinical samples from 35 tumor types.

The FDA approved FoundationOne CDx as a companion diagnostic for alpelisib in combination with fulvestrant to treat certain PIK3CA-mutated breast cancers.

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 diagnostic can now be used to identify patients with head and neck squamous cell carcinoma who may benefit from first-line treatment with Keytruda.

The LeukoStrat CDx FLT3 Mutation Assay is a PCR-based test for internal tandem duplications and tyrosine kinase domain mutations D835 and I836 in the FLT3 gene.

In order to be eligible for the drug, patients must have NTRK fusions, which may be determined via various tests including NGS and FISH.

Physicians can now use the Dako PD-L1 IHC 22C3 pharmDx assay to identify urothelial carcinoma patients who may benefit from the anti-PD1 immunotherapy.

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