Original from: 360dx

Burning Rock Biotech and drugmaker Dizal said Thursday that they have received approval from China's National Medical Products Administration (NMPA) for a next-generation sequencing-based companion diagnostic for the lung cancer drug sunvozertinib.

Dizal's sunvozertinib is an irreversible EGFR inhibitor approved by the NMPA in mid-2023 for the treatment of advanced non-small cell lung cancer (NSCLC) in patients with EGFR exon 20 insertion mutations following platinum-based chemotherapies, according to the Chinese companies. 

The newly approved test is based on Burning Rock's LungCure CDx, an NGS-based kit for the detection of multiple mutation statuses for nine genes including EGFR, MET, ERBB2, KRAS, BRAF, PIK3CA, ALK, ROS1, and RET. The NMPA approved the kit in early 2022, the companies said.

In May, Burning Rock partnered with Bayer to develop NGS-based companion diagnostic tests for the Chinese market. It struck a similar deal with Boehringer Ingelheim about a year ago.

Source: Burning Rock, Dizal Get Chinese Approval for Lung Cancer CDx