Necitumumab (Portrazza) Approved for Lung Cancer in US

Zosia Chustecka


November 24, 2015

A novel approach to the treatment of lung cancer has just been approved by the US Food and Drug Administration (FDA) ― a monoclonal antibody that targets epidermal growth factor receptor (EGFR), necitumumab (Portrazza, Eli Lilly and Company).

Necitumumab has been approved for use in combination with two forms of chemotherapy, gemcitabine (Gemzar, Eli Lilly and Company) and cisplatin (Platinol, HQ Specialty Pharma), in patients with metastatic squamous non–small cell lung cancer (NSCLC) who have not been previously treated.

"Today's approval provides certain patients with squamous cell lung cancer a new option that may extend survival," said Richard Pazdur, MD, director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research.

Data supporting the approval come from the SQUIRE trial, conducted in 1093 patients, which showed a 1.6-month improvement in overall survival (OS) when necitumumab was added to a regimen of gemecitabine and cisplatin. The median OS was 11.5 months, compared with 9.9 months on the doublet of gemcitabine and cisplatin.

"This is a marginal benefit," commented James Liebmann, MD, assistant professor of medicine at the University of Massachusetts, in Worcester, speaking at the FDA Oncologic Drugs Advisory Committee meeting in July 2015, in which the drug was reviewed. He added, however, "It's a marginal benefit in exactly the same range as everything else that's been approved for this disease."

At the same meeting, David Gandara, MD, who spoke on behalf of Lilly, said that median OS in squamous NSCLC has barely budged since the early 2000s, with platinum-based therapy being the mainstay. "All therapies are palliative — not curative," added Dr Gandara, director of the thoracic oncology program at University of California, Davis.

Necitumab is approved for use only in squamous NSCLC, which constitutes about a third of all lung cancers. NSCLC is primarily due to heavy tobacco use, but not always, according to information released by the FDA at that meeting. The majority of patients with the squamous form present with locally advanced or metastatic disease; the 5-year survival is less than 5%, the agency said.

Necitumumab was not active in nonsquamous NSCLC. A large trial, known as INSIPIRE, showed no benefit when the product was added to chemotherapy with cisplatin and pemetrexed (Alimta, Eli Lilly and Company) in nonsquamous disease.

The FDA notes that the most common side effects of necitumumab are skin rash and magnesium deficiency (hypomagnesemia), which can cause muscular weakness, seizure, irregular heartbeats, and can be fatal. The drug carries a boxed warning to alert healthcare providers of serious risks of treatment with necitumumab, including cardiac arrest and sudden death, in addition to hypomagnesemia.


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