Xiuning Le: BAY88 has received USA FDA and Chinese NMPA BTD status for pre-treated HER2-mutant NSCLC

Xiuning Le shared a post by Bayer Oncology on LinkedIn, adding:

“BAY88 has received USA FDA and Chinese NMPA breakthrough destinations (BTD) status for pre-treated HER2-mutant NSCLC, which is 2-4% of all lung cancers.

Given that there are around 2.5 million new lung cancer diagnosis yearly world-wide, HER2 mutation NSCLC will be at least 50,000 new cases per year. With new data showing BAY88 72% response rate 8.7 months duration of response, we hope we positively impact patient outcomes!”

Quoting Bayer’s post:

“WCLC24 update.
Xiuning Le presented the latest results from the phase 1/2 SOHO-01 study in patients with HER2-mutant non-small cell lung cancer.

Learn more.
Abstract: PL04.03, Oral Presentation.”

Source: Xiuning Le/LinkedIn and Bayer/LinkedIn

Xiuning Le, MD, serves as the Deputy Section Chief of Thoracic Medical Oncology at MD Anderson Cancer Center, where she oversees clinical research, including strategic planning and the operation of clinical trials within the department. She is also an Associate Professor and a leading translational researcher, specializing in resistance mechanisms, cancer genetics and genomics, biomarkers, and radiomics.