• The U.S. Food and Drug Administration (FDA) has granted a Breakthrough Therapy Designation to a drug for treating a specific type of non-small cell lung cancer (NSCLC).
• Called telisotuzumab vedotin and sold as Telsio-V, the drug is the first of its kind for treating NSCLC with an overexpression of a protein called c-Met.
• A phase 2 clinical trial shows people with NSCLC with intermediate to high c-Met expression responded well to the therapy.

The FDA has approved fast-tracking a first-of-its kind treatment for a specific type of NSCLC, one that overproduces a protein called c-Met. The drug — called telisotuzumab vedotin and branded as Telsio-V by drugmaker AbbVie — has earned the FDA’s Breakthrough Therapy Designation based on results in phase 2 clinical trial.

The FDA grants Breakthrough Therapy Designation to drugs that show promising results in early clinical trials and that perform significantly better than already-approved therapies. The designation allows the FDA to speed up the development and approval process of a drug, making it available more quickly to those who need it.

Lung cancer is the second-most common cancer type in the United States, but it remains the leading cause of cancer-related deaths. NSCLC accounts for around 85 percent of all lung cancer cases.

Telisotuzumab vedotin is specifically designed to treat advanced or metastatic nonsquamous NSCLC with an overexpression of c-Met, a cancer-associated protein. The overproduction of a protein can be harmful to cells, because it puts a strain on the cell’s resources to perform its normal tasks. Currently, there are no FDA-approved therapies available to specifically treat people with this type of NSCLC.

The drug is a special type of therapy known as an antibody-drug conjugate. It combines the science of monoclonal antibodies — used in biologic therapies — with a drug by chemically linking the two together. The antibody binds to the cancer cell, and the drug enters the cell to kill it without harming nearby cells.

Results from a phase 2 clinical trial showed an overall response rate of 53.8 percent in people with high c-Met expression and 25 percent in those with intermediate expression.

To receive this therapy, a person must have had platinum-based chemotherapy and had their cancer progress while on or after treatment.