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Thermo Fisher has also applied to the Japanese Ministry of Health, Labor, and Welfare to expand the use of the Oncomine Dx Target test in Japan.
The committee recommended the tumor-agnostic drug for use in the Cancer Drugs Fund while awaiting mature survival data from ongoing clinical trials.
In a Phase Ia/Ib study, the anti-TIGIT antibody and Tecentriq combination had better anti-tumor activity than tiragolumab alone, particularly in PD-L1 expressing lung cancers.
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.
The decision is based on pooled single-arm trial data demonstrating the agent's ability to prolong progression-free survival and shrink patients' tumors.
The studies highlighted the activity of three drugs in NSCLC patients characterized by HER2 mutations, CECAM5 overexpression, and high PD-L1 expression.
The companies plan to enroll 1,000 patients with lung cancer to assess whether technology-enabled trial enrollment can expand access to precision oncology to more patients.
The latest approval is immunotherapy Tecentriq's fourth indication in non-small cell lung cancer and fifth indication in lung cancer.
The prospective study will combine real-world, clinical, and genomic data to streamline lung cancer clinical trials and find treatment-response biomarkers.
Data amassed by analytics firm Diaceutics suggests fewer patients are coming into healthcare facilities and missing the chance for diagnosis, molecular testing, and treatment.