HER2 Biomarkers

The NDA, based on data from a randomized Phase II trial, is for the use of tucatinib combined with trastuzumab and capecitabine for HER2-positive breast cancer patients.

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

Acepodia's off-the-shelf cell therapy uses an antibody-cell conjugate to target human HER2-expressing solid tumors.

Enhertu received accelerated approval based on data from a Phase II trial that reported a 60 percent overall response rate.

In a randomized trial, tucatinib with chemotherapy improved progression-free survival in patients with locally advanced or metastatic breast cancer.

Investigators at the San Antonio Breast Cancer Symposium reported median progression free survival of 16.4 months for those who got the target dose of the drug.

Investigators provided updated evidence that that the combined treatment prevents more women from relapsing, especially higher-risk node-positive patients.

Roche noted that it expects the European Commission to approve trastuzumab emtansine in the near future, based on the EMA committee's recommendation.