The U.S. Food and Drug Administration said on Friday it has approved Boehringer Ingelheim’s drug for patients with a type of advanced lung cancer who have received prior treatment.
The drug, branded as Hernexeos, is intended for previously treated patients with non-squamous non-small cell lung cancer whose tumors have a specific genetic mutation.
The regulator’s approval was based on a study in which Hernexeos helped about 75% of patients who received prior chemotherapy achieve a complete disappearance of cancer or reduction in tumor size.
The FDA also approved Life Technologies’ diagnostic device to identify patients eligible for the treatment.
Hernexeos belongs to a class of drugs known as kinase inhibitors, which target mutations in specific proteins in the body that lead to abnormal cell growth.
The drug comes with warnings for possible liver damage, heart problems, lung inflammation and risks to unborn children. The recommended dose depends on the patient’s weight and is taken once daily.
