FDA Approves Necitumumab (Portrazza) for Advanced Squamous NSCLC

November 25, 2015

The FDA has approved necitumumab (Portrazza) in combination with chemotherapy for the treatment of patients with metastatic squamous non-small-cell lung cancer.

The US Food and Drug Administration (FDA) announced approval of necitumumab (Portrazza), a monoclonal antibody designed to block the ligand binding site of epidermal growth factor receptor 1 (EGFR), for the first-line treatment of metastatic squamous non–small-cell lung cancer (NSCLC). The drug is approved for use in combination with gemcitabine and cisplatin.

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

Necitumumab was granted orphan drug status by the FDA, a designation reserved for drugs that show promise in rare diseases or conditions.

The drug’s approval is based on results of the SQUIRE trial, a multicenter, 26-country phase III study comparing necitumumab, gemcitabine, and cisplatin to the latter two drugs alone in patients with metastatic squamous NSCLC. The trial included a total of 1,093 patients; 91% of those had a baseline performance status of 0 or 1.

The necitumumab patients had significantly better overall survival, with a hazard ratio (HR) of 0.84 (95% confidence interval [CI], 0.74–0.96; P = .01). The median overall survival was 11.5 months in that group, compared with 9.9 months in the gemcitabine and cisplatin alone group.

Progression-free survival was also significantly improved with the study drug, with a median of 5.7 months compared with 5.5 months, yielding an HR of 0.85 (95% CI, 0.74–0.98; P = .02). Overall response rate was not significantly different between the groups, at 31% for necitumumab and 29% for the control group (P = .40).

The new approval includes a warning regarding certain serious risks with necitumumab, including the risk of cardiac and sudden death as well as hypomagnesemia. In the SQUIRE trial, cardiopulmonary arrest or sudden death occurred in 15 necitumumab patients (3%), compared with 3 patients in the control group (0.6%). Other side effects of all grades included rash, vomiting, diarrhea, and dermatitis acneiform.

“We have seen advances in lung cancer in the last 20 years, but not for the initial treatment of patients battling metastatic squamous NSCLC,” said Richard Gaynor, MD, senior vice president for product development and medical affairs at Lilly Oncology, in a press release. “This is a complex disease and there is an urgent need for effective, first-line treatments.”