FDA approves Lilly’s Portrazza

SILVER SPRING, Md. — The Food and Drug Administration has given the green light to a new treatment for metastatic squamous non-small cell lung cancer, or NSCLC, in patients who haven’t received previous treatment, in combination with two forms of chemotherapy. In a study, patients taking Eli Lilly & Co.’s Portrazza alongside chemotherapy lived 11.5 months longer than the 9.9 months those only undergoing chemotherapy did. 

 

“Lung cancer tumors can be varied, so treatment options need to be tailored to the specific type of lung cancer in the patient,” said Dr. Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “Today’s approval provides certain patients with squamous cell lung cancer a new option that may extend survival.” 

 

Portrazza will include a boxed warning about the risk of cardiac arrest and sudden death, as well as hypomagnesemia (magnesium deficiency).