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.
Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by regular mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Actual drug patent expiration dates and a availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval. Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability. All trademarks are the property of their respective owners.
*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.