Posted from: Monday, December 28, 2015 - 10:47 AM - Present

FDA Approves Portrazza for the Treatment of Lung Cancer

November 24, 2015 – The U.S. Food and Drug Administration (FDA) granted Lilly approval for Portrazza (necitumumab) for the first-line treatment of patients with metastatic squamous non-small cell lung cancer (NSCLC) in combination with gemcitabine and cisplatin. Portrazza is an epidermal growth factor receptor antagonist with its activation linked to the growth and spread of tumors. Of the more than 220,000 Americans diagnosed with lung cancer each year, NSCLC accounts for 85% of the cases; of which about 30% are squamous cell carcinomas and 70% are non-squamous cell carcinomas. Results from Portrazza clinical trial showed that it improved overall survival by 1.6 months when added to gemcitabine and cisplatin compared to gemcitabine and cisplatin alone at 11.5 months versus 9.9 months. Recommended dose of Portrazza is 800mg, given as a 60-minute intravenous infusion, on Days 1 and 8 of each 21-day cycle. Launch date for Portrazza is December 2015, through a limited specialty network. 

 

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Last Updated Monday, May 29, 2017 - 10:37 AM.