ALK Biomarkers

The approval was based on data showing superior efficacy for Alunbrig compared to Pfizer's Xalkori, especially in patients with brain metastasis.

The approval presents another treatment option for the 3 percent to 5 percent of metastatic NSCLC patients with ALK rearrangements.

The positive committee opinion is based on data from the Phase III ALTA-1L trial, which is also supporting the drug's US application for a first-line indication.

The company is seeking to expand the use of the drug as a first-line treatment after it received accelerated approval from the FDA in 2017 for those who failed on Xalkori.

The high-throughput S2000 sequencer is the second instrument Genetron Health has received NMPA approval for, following the S5 benchtop instrument last year.

The company will use its InVisionFirst-Lung test to study resistance mutations in patients treated with Pfizer's ALK inhibitor lorlatinib.

A collection of biomarker- and genomic testing-driven precision oncology research presented at the European Society of Medical Oncology Congress.

Results from the CheckMate-227 trial provided evidence for the use of nivolumab and ipilimumab in combination, while the FLAURA study focused on osimertinib.

The recommendation is based on a study in which NSCLC patients without EGFR mutations or ALK rearrangements lived longer on the combo than just on chemo.