Despite recognition among drugmakers, researchers, and regulators of the need to diversify precision oncology trials, few Black and Hispanic patients are included in studies.
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.
Results from the CheckMate-227 trial provided evidence for the use of nivolumab and ipilimumab in combination, while the FLAURA study focused on osimertinib.
An IASLC survey showed that molecular testing is not performed in line with expert guidelines, which means only a minority of lung cancer patients are benefitting from precision oncology.
