FDA Approves Portrazza (panitumumab) for advanced squamous NSCLC

November 24, 2015 - The Food and Drug Administration of the United States today to treat squamous Portrazza (of necitumumab) in combination with two forms of chemotherapy in patients with advanced (metastatic) NSCLC (NSCLC) who did not receive drugs have been targeted for treatment of their advanced lung cancer.
Lung cancer is the leading cause of cancer death in the United States, with about 221.200 new diagnostics and 158.040 deaths in 2015. The most common type of lung cancer, non-small cell lung cancer, will continue in two types appointed divided main cell types found in the cancer - squamous cell carcinoma and not (which includes adenocarcinoma).
"Lung cancer can be changed so that the treatment options need to be tailored to the specific type of lung cancer patients," said Richard Pazdur, MD, director of the Office of Hematology and Oncology Products in the FDA's Center for evaluation and drug research. "Today's approval provides some lung cancer patients with squamous cell a new option that can extend survival time."
Portrazza is a monoclonal antibody, usually found the activity of the EGFR, a squamous NSCLC tumor protein.
The safety and efficacy of Portrazza were evaluated in a multicenter, randomized, open clinical study with squamous NSCLC advanced 1093 participants who receive cisplatin and gemcitabine chemotherapy with or without Portrazza. Portrazza the participants and cisplatin plus gemcitabine lived longer on average (11.5 months) compared to those who do gemcitabine and cisplatin (9.9 months). Portrazza was not found to be an effective treatment for patients with non-squamous NSCLC.
The most common side effects are rash and magnesium deficiency Portrazza (hypomagnesemia), muscle weakness, seizures, may cause cardiac arrhythmia, and can be fatal. Portrazza includes a warning to health care providers more serious risks of treatment with Portrazza, including cardiac arrest and sudden death, and alert hypomagnesemia.
Portrazza is marketed by Eli Lilly and Company, Indianapolis, Indiana basis.