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The company, which uses fruit fly "avatars" to screen drugs, will be collaborating with London IVD Co-operative and Genomics England to test their technology in GI cancer patients.
The European Commission will review CHMP's recommendation and issue a decision on marketing authorization for the drug by the end of September.
The company recently presented results from its Aurora assay for multi-cancer screening and plans to launch a $100 test for the US and Chinese markets.
The Phase II DESTINY-CRC01 and DESTINY-Gastric01 underscore the importance of HER2 testing in patients with colorectal cancers and gastric cancers, respectively.
Investigators are building upon an initial case study that allowed them to assess how well ctDNA captured a cancer's full genomic heterogeneity compared to tissue biopsies.
In a Phase II study, the drug demonstrated superiority over investigator's choice of chemotherapy in patients with advanced disease.
The company submitted a supplemental NDA for the antibody drug conjugate based on objective response and overall survival data from the Phase II DESTINY-Gastric01 trial.
The analysis involving GI patients in Germany showed that integrating NGS and WES into practice identified more germline variants and identified unique treatment options.
The company also plans to submit a new drug application for avapritinib in mainland China in the first half of this year.
The trial evaluated the safety and preliminary activity of the single-agent therapy for FGFR2b-overexpressing gastric cancers.