December 2015, Vol. 4, No. 6
FDA Approves Portrazza to Treat Advanced Squamous Non–Small Cell Lung Cancer
On November 24, 2015, the FDA approved Portrazza (necitumumab) in combination with 2 forms of chemotherapy to treat patients with advanced (metastatic) squamous non–small cell lung cancer (NSCLC) who have not previously received medication specifically for treating their advanced lung cancer.
Lung cancer is the leading cause of cancer death in the United States, with 221,200 new diagnoses and 158,040 deaths estimated for 2015. The most common type of lung cancer, non–small cell lung cancer, is further divided into 2 main types named for the kinds of cells found in the cancer—squamous cell and nonsquamous cell (which includes adenocarcinoma).
“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’s Center for Drug Evaluation and Research. “Today’s approval provides certain patients with squamous cell lung cancer a new option that may extend survival.”
Portrazza is a monoclonal antibody that blocks activity of the epidermal growth factor receptor, a protein commonly found on squamous NSCLC tumors.
The safety and efficacy of Portrazza were evaluated in a multicenter, randomized, open-label clinical study of 1093 participants with advanced squamous NSCLC who received gemcitabine and cisplatin with or without Portrazza. Those taking Portrazza plus gemcitabine and cisplatin lived longer on average (11.5 months) compared with those only taking gemcitabine and cisplatin (9.9 months). Portrazza was not found to be an effective treatment in patients with nonsquamous NSCLC.
The most common side effects of Portrazza are skin rash and hypomagnesemia, which can cause muscular weakness, seizure, and irregular heartbeats, and can be fatal. Portrazza includes a boxed warning to alert healthcare providers of serious risks of treatment with Portrazza, including cardiac arrest and sudden death, as well as hypomagnesemia.
On November 23, 2015, the FDA approved Opdivo (nivolumab) to treat patients with advanced (metastatic) renal cell carcinoma, a form of kidney cancer, who have received a certain type of prior therapy. “Opdivo provides an important therapy option for patients with renal cell carcinoma,” said Richard Pazdur, MD, Director of [ Read More ]
(PMO) is a proud partner of the Personalized Medicine Coalition (PMC). PMO and PMC share the common goal of promoting the understanding and adoption of personalized medicine concepts to ultimately benefit patients and the health system. PMC provides opinion leadership on policy issues that affect personalized medicine; helps to educate [ Read More ]