U.S. FDA Grants Breakthrough Therapy Designation to Bayer’s BAY 2927088
Bayer announced that the Centre for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) and the U.S. FDA have granted Breakthrough Therapy designation to BAY 2927088.
This investigational drug is intended for adults with unresectable or metastatic non-small cell lung cancer (NSCLC) who carry HER2 (ERBB2) mutations and have already received systemic treatment.
The Breakthrough Therapy designations by both the CDE and the U.S. FDA highlight the potential of BAY 2927088 to address the needs of patients with HER2-mutant NSCLC, a form of lung cancer that offers limited treatment options and typically has a poor prognosis. Promising clinical evidence supports the designations, reinforcing Bayer’s commitment to advancing cancer treatment, particularly in the field of targeted therapies.
The Breakthrough Therapy designation is based on early clinical evidence from a Phase I/II open-label, multicenter study (NCT05099172) assessing the safety, pharmacokinetics, and initial efficacy of BAY 2927088 in adults with advanced non-small cell lung cancer (NSCLC) that have HER2 or EGFR mutations.
This designation is part of a process designed to speed up the development and review of new treatments for serious or life-threatening conditions where no adequate treatments exist, or where the new therapy shows significant advantages over current options.
BAY 2927088 is still under investigation and has not yet been approved by health authorities. It is an oral, reversible tyrosine kinase inhibitor (TKI) that specifically targets mutant forms of HER2 and EGFR, showing greater selectivity for mutant EGFR compared to the wild type. It is under development as a potential treatment for patients with non-small cell lung cancer (NSCLC) who have HER2 mutations.
Non-small cell lung cancer (NSCLC) is the leading cause of cancer-related deaths worldwide, accounting for over 85% of lung cancer cases. Activating HER2 mutations are present in 2% to 4% of advanced NSCLC cases. Around 80% of NSCLC diagnoses occur at advanced stages, making treatment more challenging. Currently, there are no fully approved therapies for NSCLC patients with HER2 mutations.
