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The firms are developing a kit-based CDx to detect NTRK gene fusions, including NTRK1, NTRK2 and NTRK3, for Bayer's Vitrakvi cancer treatment.
The accelerated approval was granted based on data submitted from the Phase I/II LIBRETTO-001 trial.
The agency reviewed data showing that HRD-positive patients on the olaparib/bevacizumab combination had median progression-free survival of 37.2 months.
The tool, which has been validated in two independent patient cohorts, uses artificial intelligence to predict patients likely to benefit from upfront FOLFOX.
The oral MET inhibitor, marketed as Tabrecta, is for patients whose tumors have a mutation that leads to MET exon 14 skipping as detected by a Foundation Medicine test.
Data presented at ACMG's online annual meeting suggests that more than 10 percent of prostate cancer patients across disease stages carry inherited cancer-related variants.
The company, which recently wrapped enrollment for a Phase II trial in China, is continuing to actively enroll patients in the US trial for the drug despite the COVID-19 pandemic.
The drugmaker will cover the cost of testing for up to 500 patients in the US with MSI-high colorectal cancer or RAI-refractory differentiated thyroid cancer.
Early sub-protocol results presented at AACR meeting hint at better outcomes for Mektovi-treated cases with NRAS codon 61 tumor mutations.
Investigators from the Friends of Cancer Research's tumor mutational burden harmonization project shared new data this week at AACR's virtual meeting.