FDA Approves Non-Small Cell Lung Cancer Drug

Portrazza plus chemotherapy treats metastatic squamous non-small cell lung cancer in patients who were not previously treated specifically for advanced lung cancer.

The FDA on Tuesday approved a new treatment option for patients with advanced lung cancer.

Necitumumab (Portrazza) was approved for use in combination with 2 forms of chemotherapy to treat patients with metastatic squamous non-small cell lung cancer (NSCLC) who previously received medication specifically for treatment of their advanced lung cancer.

Portrazza acts as a monoclonal antibody that blocks EGFR protein activity commonly found on squamous NSCLC tumors.

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

A multicenter, randomized, open-label clinical study evaluated Portrazza in 1093 patients with advanced squamous NSCLC who were administered chemotherapy drugs gemcitabine and cisplatin with or without Portrazza.

Patients in the Portrazza plus gemcitabine and cisplatin group lived longer at an average of 11.5 months compared with an average of 9.9 months in patients only taking gemcitabine and cisplatin. Portrazza was not deemed effective in the treatment of patients with non-squamous NSCLC.

Common side effects in Portrazza are skin rash and magnesium deficiency, which may lead to muscular weakness, seizure, irregular heartbeats, and can be fatal. The drug also includes a boxed warning for serious treatment risks, including cardiac arrest, hypomagnesemia, and sudden death.

“This FDA approval represents an important step forward in the treatment of people battling a devastating and difficult-to-treat form of cancer that has seen few advances over the past 2 decades,” Richard Gaynor, MD, senior vice president, product development and medical affairs for Lilly Oncology said in a release. “We are determined to continue delivering on our commitment of providing new, valuable treatment options to people living with cancer.”