FDA grant Breakthrough Therapy Designation to telisotuzumab vedotin

pharmafile | January 6, 2022 | News story | Business Services  

AbbVie’s investigational telisotuzumab vedotin has been granted Breakthrough Therapy Designation by the FDA for the treatment of patients with advanced or metastatic epidermal growth factor receptor (EGFR) wild type, nonsquamous non-small cell lung cancer with high levels of c-Met overexpression whose disease has progressed on or after platinum-based therapy.

“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, MD, PhD, 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.”

The FDA’s Breakthrough Therapy Designation program is designed 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. This generally refers to an endpoint that measures an effect on irreversible morbidity or mortality (IMM) or on symptoms that represent serious consequences of the disease. It can also refer to findings that suggest an effect on IMM or serious symptoms.

Despite advances in treatment, lung cancer remains the leading cause of cancer-related deaths in both men and women in the US, and throughout the world. It is the most common cancer in men, and the third most common cancer in women worldwide, with incidence rates (per 100,000) of 31.5 and 14.6, respectively. Approximately 85% of lung cancers are classified as non-small cell lung cancer.

Patients whose disease progresses after standard of care therapies, including prior platinum, have limited treatment options and poor prognosis.

Ana Ovey

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