Portrazza Approved for Squamous NSCLC

The United States Food and Drug Administration (FDA) approved Portrazza (necitumumab) for the treatment of advanced, squamous non-small cell lung cancer in patients who have not received prior therapy for their advanced disease. Portrazza is to be used in combination with the two chemotherapy agents, gemcitabine and cisplatin.

Portrazza is the first biologic agent to be approved as first-line treatment for advanced, squamous non-small cell lung cancer.

Non-small cell lung cancer (NSCLC) is the most common form of lung cancer, comprising approximately 80-85% of all lung cancers. Patients with NSCLC have their cancer further divided into two main groups: squamous and non-squamous, depending upon the kind of cells that are cancerous within the lung. Squamous lung cancer comprises approximately 30% of lung cancers.

Portrazza is an agent that blocks activity of the epidermal growth factor receptor (EGFR). The EGFR is involved in cellular growth and replication; therefore, blocking the effects of EGFR can slow or reduce a cancer cell’s growth, ultimately shrinking the size of cancer, or halting its progression for an extended period of time.

The latest trial evaluating the effectiveness and safety of Portrazza, referred to as the SQUIRE trial, included 1,093 patients with advanced, squamous NSCLC. The trial took place in 26 countries, and 91% of patients had cancer that had spread outside the lungs to at least 2 different sites in their body.

Patients were divided into two groups: one group was treated with Portrazza plus gemcitabine plus cisplatin, and the other group was treated with gemcitabine/cisplatin only. The two groups of patients were then directly compared.

The average survival time was 11.5 months for patients treated with Portrazza/gemcitabine/cisplatin, compared to 9.9 months for those treated with gemcitabine/cisplatin only.
Portrazza was not found to be effective among patients with non-squamous NSCLC
The most common side effects associated with Portrazza were skin rash and low levels of magnesium.
Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, stated in the FDA news release announcing the approval of Portrazza, that “Lung cancer tumors can be varied, so treatment options need to be tailored to the specific type of lung cancer in the patient. Today’s approval provides certain patients with squamous cell lung cancer a new option that may extend survival.”

Reference: United States Food and Drug Administration. News release. FDA approves Portrazza to treat advanced squamous non-small cell lung cancer. Available at: Accessed November 24, 2015.