Pemfexy FDA Approval History
Last updated by Judith Stewart, BPharm on Dec 21, 2022.
FDA Approved: Yes (First approved February 8, 2020)
Brand name: Pemfexy
Generic name: pemetrexed
Dosage form: Injection
Company: Eagle Pharmaceuticals, Inc.
Treatment for: Non-Small Cell Lung Cancer, Malignant Pleural Mesothelioma
Pemfexy (pemetrexed for injection) is a branded alternative to Alimta for the treatment of nonsquamous non-small cell lung cancer and malignant pleural mesothelioma.
Pemfexy is a folate analog metabolic inhibitor indicated:
- 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.
- in combination with cisplatin for the initial treatment of patients with locally advanced or metastatic non-squamous, non-small cell lung cancer (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 non-small cell lung cancer. - 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.
Development timeline for Pemfexy
Further information
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