pemetrexed
pemetrexed is listed in the FDA National Drug Code directory with 4 NDC codes, marketed under brand names including Pemfexy, AXTLE. Available dosage forms: injection, injection, powder, lyophilized, for solution.
Drug Details
- Generic Name
- pemetrexed
- Brand Names
- Pemfexy, AXTLE
- Application Number
- NDA209472
- Sponsor
- Acacia Pharma, Ltd.
- NDC Codes
- 4
- Dosage Forms
- INJECTION, INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Routes
- INTRAVENOUS
- Active Ingredients
- PEMETREXED MONOHYDRATE, PEMETREXED
Indications and Usage
1 INDICATIONS AND USAGE PEMFEXY™ is a folate analog metabolic inhibitor indicated for: in combination with pembrolizumab and platinum chemotherapy, for the initial treatment of patients with metastatic non-squamous NSCLC, with no EGFR or ALK genomic tumor aberrations. ( 1.1 ) in combination with cisplatin for the initial treatment of patients with locally advanced or metastatic non-squamous, non-small cell lung cancer (NSCLC). ( 1.1 ) as a single agent for the maintenance treatment of patients with locally advanced or metastatic non-squamous NSCLC whose disease has not progressed after four cycles of platinum-based first-line chemotherapy. ( 1.1 ) as a single agent for the treatment of patients with recurrent, metastatic non-squamous NSCLC after prior chemotherapy. ( 1.1 ) Limitations of Use : PEMFEXY is not indicated for the treatment of patients with squamous cell non-small cell lung cancer. ( 1.1 ) in combination with cisplatin for the initial treatment, of patients with malignant pleural mesothelioma whose disease is unresectable or who are otherwise not candidates for curative surgery. ( 1.2 ) 1.1 Non-squamous Non-Small Cell Lung Cancer PEMFEXY ™ is indicated: in combination with pembrolizumab and platinum chemotherapy, for the initial treatment of patients with metastatic non-squamous non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations. in combination with cisplatin for the initial treatment of patients with locally advanced or metastatic, non-squamous NSCLC. as a single agent for the maintenance treatment of patients with locally advanced or metastatic non-squamous NSCLC whose disease has not progressed after four cycles of platinum-based first-line chemotherapy. as a single agent for the treatment of patients with recurrent, metastatic non-squamous NSCLC after prior chemotherapy. Limitations of Use : PEMFEXY is not indicated for the treatment of patients with squamous cell NSCLC [see Clinical Studies 14.1 ]. 1.2 Mesothelioma PEMFEXY is indicated in combination with cisplatin for the initial treatment of patients with malignant pleural mesothelioma whose disease is unresectable or who are otherwise not candidates for curative surgery.