FDA Expands Approval of Eagle’s Pemfexy for NSCLC

The FDA has expanded its approval of Eagle Pharmaceuticals’ Pemfexy (pemetrexed injection) in combination with pembrolizumab and platinum chemotherapy as a first treatment for metastatic, non-squamous, nonsmall-cell lung cancer (NSCLC) with no EGFR or ALK genomic tumor aberrations.

Pemfexy is a ready-to-dilute liquid intravenous formulation, which eliminates the need for reconstitution.

This is the fifth indication for which the drug has received approval. Pemfexy is also indicated for other forms and stages of NSCLC and for certain patients with malignant pleural mesothelioma.