AbbVie was granted Breakthrough Therapy Designation (BTD) from the U.S. FDA for investigational telisotuzumab vedotin (Teliso-V) for the treatment of patients with advanced/metastatic epidermal growth factor receptor (EGFR) wild type, nonsquamous non-small cell lung cancer (NSCLC) with high levels of c-Met overexpression whose disease has progressed on or after platinum-based therapy.
 
The FDA’s BTD program is intended to expedite the development and review of medicines with preliminary clinical evidence that indicate that the investigational treatment may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints.
 
Despite advances in treatment, lung cancer remains the leading cause of cancer-related deaths in both men and women in the U.S. and throughout the world. Approximately 85% of lung cancers are classified as NSCLC. Patients whose disease progresses after standard of care therapies, including prior platinum, have limited treatment options and poor prognosis.
 
“Patients with non-small cell lung cancer have a high unmet need and Teliso-V has the potential to provide them with an additional treatment option to manage their disease,” said Mohamed Zaki, M.D., Ph.D., Vice President and Global Head of Oncology Clinical Development at AbbVie. “Today’s announcement marks an important step in our mission to advance new oncology treatments across tumor types to improve standards of care for patients with cancer.”