The Food and Drug Administration (FDA) has approved Pemfexy® (pemetrexed for injection) in combination with pembrolizumab and platinum chemotherapy for the initial treatment of patients with metastatic, nonsquamous, non-small cell lung cancer (NSCLC) with no EGFR or ALK genomic tumor aberrations.

The ready-to-dilute formulation was developed to eliminate the reconstitution step with Alimta (pemetrexed lyophilized powder for IV infusion after reconstitution and dilution).

In addition to this new approval, Pemfexy is indicated for: 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.

Pemfexy is supplied as a solution in a multi-dose vial containing 500mg pemetrexed per 20mL (25mg/mL).

References

  1. Eagle Pharmaceuticals receives FDA approval for additional indication for Pemfexy® in combination with pembrolizumab and platinum chemotherapy. News release. Eagle Pharmaceuticals. Accessed December 19, 2022. https://www.globenewswire.com/news-release/2022/12/19/2576128/0/en/Eagle-Pharmaceuticals-Receives-FDA-Approval-for-Additional-Indication-for-PEMFEXY-in-Combination-with-Pembrolizumab-and-Platinum-Chemotherapy.html.
  2. Pemfexy. Package insert. Eagle Pharmaceuticals; 2022. Accessed December 19, 2022. https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/209472s005lbl.pdf.