Ready-to-Dilute Pemetrexed Formulation Gets Tentative FDA Approval

Formulation does not require reconstitution, reducing the potential for dosing errors
Formulation does not require reconstitution, reducing the potential for dosing errors

Eagle announced that the Food and Drug Administration (FDA) has tentatively approved Pemfexy (pemetrexed injection) ready-to-dilute formulation.

Pemfexy is indicated for the treatment of:

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

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Pemfexy does not need to be reconstituted, reducing the potential for dosing errors during mixing and the hazards of inhaling cytotoxic vapors from the powder form of the drug. Pemetrexed is a folate analog metabolic inhibitor that works by disrupting folate-dependent metabolic processes involved in cell replication.

Tentative approval indicates that the FDA has concluded the drug has met all quality, safety, and efficacy requirements but it is not eligible for U.S. marketing due to existing patent protections. 

For more information call (201) 326-5300 or visit EagleUS.com.