The U.S. Food and Drug Administration has approved an Indianapolis-based Eli Lilly and Co. (NYSE: LLY) treatment for use against lung cancer. Lilly Oncology says Portrazza, in combination with two other drugs, is the first treatment of its kind for a difficult-to-treat version of the illness.
Portrazza has been granted orphan drug status by the FDA.
Lilly Oncology Senior Vice President of Product Development and Medical Affairs Richard Gaynor "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. 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 says lung cancer is the leading cause of cancer death in the U.S. Last year, an estimated 221,200 people received a lung cancer diagnoses and more than 158,000 patients died from the disease. deaths in 2015. Non-small cell lung cancer is the most common type of the illness and it comes in two main types: squamous cell and non-squamous cell.
Portrazza has been found to block the activity of a protein commonly located on squamous non-small cell lung cancer tumors.
Director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research Richard Pazdur says "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."
In a randomized study of more than 1,000 patients with advanced cases of squamous NSCLC, those who took Portrazza plus gemcitabine and cisplatin lived more than two months longer on average than those taking the combination without Portrazza.