FDA has granted Breakthrough Therapy Designation (BTD) to Boehringer Ingelheim for zongertinib for the treatment of adult patients with advanced, unresectable, or metastatic non-small cell lung cancer (NSCLC) and who have received prior systemic therapy
This decision was based on encouraging data from the phase Ib portion of the Beamion LUNG-1 trial for zongertinib, offering hope for patients with NSCLC.
The FDA collaborated with China’s CDE, which also granted BTD to zongertinib for treating NSCLC.
Boehringer Ingelheim presented zongertinib data at the IASLC 2024 World Conference on Lung Cancer (WCLC).
Carinne Brouillon, Head of Human Pharma at Boehringer, acknowledged the FDA’s BTD for zongertinib for treating NSCLC.
He emphasized that NSCLC patients eligible were those whose tumors activate HER2 mutations and have received prior systemic therapy.
Brouillon acknowledged the significance of zongertinib as a milestone, as approximately 40,000 people worldwide are diagnosed with NSCLC annually.
She highlighted that while zongertinib, a targeted therapy, was offered for some cancers driven by HER2, individuals with HER2-mutated NSCLC have limited treatment options.
Source: Boehringer Ingelheim to unveil groundbreaking oncology research at WCLC, demonstrating strength of portfolio
https://www.boehringer-ingelheim.com/us/human-health/cancer/boehringer-ingelheim-unveil-oncology-research-wclc
