Amneal Pharmaceuticals has received 505(b)(2) New Drug Application (NDA) approval from the US Food and Drug Administration for PEMRYDI RTU, a ready-to-use presentation of pemetrexed for injection. The treatment is indicated in combination with pembrolizumab and platinum chemotherapy for initial treatment of patients with metastatic non-squamous non-small cell lung cancer with no EGFR or ALK genomic tumor aberration and for initial treatment, in combination with cisplatin, of patients with malignant pleural mesothelioma whose disease is unresectable or who are otherwise not candidates for curative surgery. Adverse effects reported include myelosuppression, renal failure, skin toxicity and radiation recall.
Amneal expects to launch this product in Q1 2024 with a J-code from the Centers for Medicare & Medicaid Services. The company said that PEMRYDI RTU would offer an advantage over other pemetrexed products because it eliminates formulation steps common in those treatments. It will be available in three vial sizes: 100mg/10mL; 500 mg/50mL; and 1,