FDA Approves New Drug Application for Oncology Injectable Pemrydi RTU

The FDA has approved a 505(b)(2) new drug application for Pemrydi RTU, the first and only ready-to-use presentation of pemetrexed (Alimta) for injection that does not require reconstitution, dilution, or refrigeration.

The formulation is indicated for use in combination with pembrolizumab (Keytruda) and platinum-based chemotherapy for the initial treatment of patients with metastatic nonsquamous non–small cell lung cancer without EGFR or ALK tumor aberrations, and in combination with cisplatin for the frontline treatment of patients with malignant pleural mesothelioma whose disease is unresectable or who are otherwise not candidates for curative surgery.

The injectable will be available in 3 vial sizes: 100 mg/10 mL; 500 mg/mL; and 1,000 mg/mL. The drug’s developer, Amneal Pharmaceuticals, plans to launch the product in the first quarter of 2024 with a J-Code from the Centers for Medicare and Medicaid Services.

“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 for medication errors. This approval represents another high-value product for our growing injectables portfolio which we expect to launch with a J-code for Pemrydi RTU,” Harsher Singh, senior vice president of Amneal Biosciences, said in a press release.

In terms of safety, common adverse effects include myelosuppression, renal failure, skin toxicity, and radiation recall.

Reference

Amneal receives 505(b)(2) NDA approval from FDA for Pemrydi Rtu, a ready-to-use oncology injectable. News release. Amneal Pharmaceuticals, Inc. June 14, 2023. Accessed June 14, 2023. https://investors.amneal.com/news/press-releases/press-release-details/2023/Amneal-Receives-505b2-NDA-Approval-from-FDA-for-PEMRYDI-RTU-a-Ready-to-Use-Oncology-Injectable/default.aspx