necitumumab
Drug Details
- Generic Name
- necitumumab
- Brand Names
- Portrazza
- Application Number
- BLA125547
- Sponsor
- Eli Lilly and Company
- NDC Codes
- 1
- Dosage Forms
- SOLUTION
- Routes
- INTRAVENOUS
- Active Ingredients
- NECITUMUMAB
Indications and Usage
1 INDICATIONS AND USAGE PORTRAZZA™ is an epidermal growth factor receptor (EGFR) antagonist indicated, in combination with gemcitabine and cisplatin, for first-line treatment of patients with metastatic squamous non-small cell lung cancer. ( 1.1 ) Limitation of Use: PORTRAZZA is not indicated for treatment of non-squamous non-small cell lung cancer. ( 1.2 , 5.6 , 14.2 ) 1.1 Squamous Non-Small Cell Lung Cancer (NSCLC) PORTRAZZA™ is indicated, in combination with gemcitabine and cisplatin, for first-line treatment of patients with metastatic squamous non-small cell lung cancer. 1.2 Limitation of Use PORTRAZZA is not indicated for treatment of non-squamous non-small cell lung cancer [see Warnings and Precautions ( 5.6 ) and Clinical Studies ( 14.2 )] .