axitinib
axitinib is listed in the FDA National Drug Code directory with 4 NDC codes, marketed under brand name including INLYTA. Available dosage form: tablet, film coated.
Drug Details
- Generic Name
- axitinib
- Brand Names
- INLYTA
- Application Number
- NDA202324
- Sponsor
- Pfizer Laboratories Div Pfizer Inc
- NDC Codes
- 4
- Dosage Forms
- TABLET, FILM COATED
- Routes
- ORAL
- Active Ingredients
- AXITINIB
Indications and Usage
1 INDICATIONS AND USAGE INLYTA is a kinase inhibitor indicated: • in combination with avelumab, for the first-line treatment of patients with advanced renal cell carcinoma (RCC). ( 1.1 ) • in combination with pembrolizumab, for the first-line treatment of patients with advanced RCC. ( 1.1 ) • as a single agent, for the treatment of advanced renal cell carcinoma (RCC) after failure of one prior systemic therapy. ( 1.2 ) 1.1 First-Line Advanced Renal Cell Carcinoma INLYTA in combination with avelumab is indicated for the first-line treatment of patients with advanced renal cell carcinoma (RCC). INLYTA in combination with pembrolizumab is indicated for the first-line treatment of patients with advanced RCC. 1.2 Second-Line Advanced Renal Cell Carcinoma INLYTA as a single agent is indicated for the treatment of advanced RCC after failure of one prior systemic therapy.