Pemfexy, a Ready-to-Dilute Formulation of Pemetrexed, Gets Final FDA Approval

Final approval by the Food and Drug Administration (FDA) has been granted to Pemfexy™ (pemetrexed for injection; Eagle Pharmaceuticals), an  alternative to Alimta® (Eli Lilly), for the treatment of non-small cell lung cancer (NSCLC) and malignant pleural mesothelioma. 

Pemfexy was granted tentative approval in 2017, though the Company was not able to market due to existing patent protections. Last December, an agreement was reached that would allow for an initial entry of Pemfexy into the market on February 1, 2022, and then a full entry on April 1, 2022. 

Pemfexy is a ready-to-dilute formulation indicated for the treatment of: 

• Locally advanced or metastatic nonsquamous non-small NSCLC in combination with cisplatin; 
• Locally advanced or metastatic nonsquamous NSCLC in patients whose disease has not progressed after 4 cycles of platinum-based first-line chemotherapy, as a single agent for maintenance treatment; 
• Locally advanced or metastatic nonsquamous NSCLC after prior chemotherapy as a single agent and;
• Malignant pleural mesothelioma in patients whose disease is unresectable or who are otherwise not candidates for curative surgery, in combination with cisplatin.

The product will be supplied as 500mg/20mL in a multi-dose vial.

For more information visit eagleus.com.