Eli Lilly Therapy for Metastatic Squamous NSCLC Gets FDA Approval

Eli Lilly Therapy for Metastatic Squamous NSCLC Gets FDA Approval

A novel treatment for a particularly deadly form of lung cancer has just been approved by the U.S. Food and Drug Administration (FDA) — Eli Lilly and Company‘s Portrazza (necitumumab) a monoclonal antibody designed to target and block the epidermal growth factor receptor (EGFR).

Portrazza (necitumumab injection for intravenous use, 800 mg/50 mL) is approved in combination with cisplatin and gemcitabine as the first biologic for the first-line treatment of patients with metastatic squamous non-small cell lung cancer (NSCLC). The drug is not indicated to treat patients with nonsquamous NSCLC. The protein EGFR has been shown in preclinical studies to have a role in the formation and spread of tumors.

Lung cancer is one of the leading causes of cancer deaths in the United States and NSCLC is one of the most common types of the disease, accounting for approximately 85 percent of all cases. Squamous cell NSCLC is more rare, about 25 to 30 percent of lung cancers, and metastatic squamous NSCLC is the disease’s most difficult to treat form, with low five-year survival rates.

“We have seen advances in lung cancer in the last 20 years, but not for the initial treatment of patients battling metastatic squamous non-small cell lung cancer. This is a complex disease and there is an urgent need for effective, first-line treatments,” said Richard Gaynor, MD, Senior Vice President, Product Development and Medical Affairs for Lilly Oncology, in a press release. “The approval of Portrazza is an important step forward that reaffirms Lilly’s commitment to discovering new treatments that respond to the needs of individual patients.”

The FDA has also granted Orphan Drug status to Portrazza, a designation given to drugs showing promise in the diagnosis and/or treatment of rare diseases.

Data supporting the approval come from SQUIRE, a randomized, open label Phase 3 clinical trial conducted in 1,093 in 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, in comparison with 9.9 months in patients treated with gemcitabine and cisplatin alone.

“Lung cancer is an extremely complicated disease that requires a variety of therapy options so doctors can choose an appropriate treatment for each patient’s unique circumstances,” said Bonnie J. Addario, founder and chair of the Bonnie J. Addario Lung Cancer Foundation, and a lung cancer survivor. “Today’s approval represents progress for patients diagnosed with metastatic squamous non-small cell lung cancer, as each new therapy advances cancer care and gives patients hope for improved outcomes.”

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