FDA approves Amneal’s 505(b)(2) NDA for PEMRYDI RTU

The US Food and Drug Administration (FDA) has approved Amneal Pharmaceuticals’ 505(b)(2) new drug application (NDA) for a ready-to-use oncology injectable, PEMRYDI RTU.

PEMRYDI RTU is indicated as an initial treatment, along with pembrolizumab and platinum chemotherapy, for metastatic non-squamous non-small cell lung cancer patients with no epidermal growth factor receptor or anaplastic lymphoma kinase genomic tumour aberration.

In combination with cisplatin, the therapy has also been indicated for the initial treatment of malignant pleural mesothelioma patients whose disease is unresectable or who are not candidates for curative surgery.

Amneal Pharmaceuticals claimed that PEMRYDI RTU is the first and only ready-to-use presentation of pemetrexed for injection.

Amneal Pharmaceuticals subsidiary Amneal Biosciences senior vice-president Harsher Singh stated: “We believe PEMRYDI RTU, the first ready-to-use version of a key oncology injectable, will offer a meaningful advantage in this improved presentation.

“By eliminating formulation steps common with other pemetrexed products, we are improving provider efficiencies while reducing the risk of medication errors.

“This approval represents another high-value product for our growing injectables portfolio which we expect to launch with a J-code [a common healthcare procedure coding system identifier] for PEMRYDI RTU.”

With a J-code from the Centers for Medicare & Medicaid Services, PEMRYDI RTU is expected to be launched in the first quarter of 2024.

The product will be offered in 500mg/50mL,100mg/10mL and 1,000mg/100mL vial sizes.

Adverse effects reported while using PEMRYDI RTU have included renal failure, radiation recall, skin toxicity and myelosuppression [reduction in bone marrow activity].