The FDA has approved a new drug called Bizengri (zenocutuzumab) for adults with two rare types of cancer that have a specific genetic change. This change is called an NRG1 gene fusion. The drug is for people with advanced non-small cell lung cancer or pancreatic cancer that has spread or cannot be removed by surgery. It is for patients whose cancer has gotten worse after other treatments.
Bizengri is a type of targeted therapy called a bispecific antibody. It works by attaching to two different proteins on cancer cells, HER2 and HER3, to help stop the cancer from growing. The approval is based on studies showing that the drug shrank tumors in some patients. The FDA granted this approval under an accelerated process, which means the company must do more studies to confirm the benefit.
This approval is important because these cancers with an NRG1 fusion are very rare and have had few treatment options. However, there is currently no FDA-approved test to find the NRG1 fusion. Doctors may use other tests to decide if a patient might benefit.
If you or a loved one has advanced lung or pancreatic cancer, talk to your doctor about whether testing for an NRG1 fusion might be right for you. This drug is not for everyone, and your doctor can help you understand if it could be a possible treatment option.