FDA Approves NDA of Cyclophosphamide Injection for Various Cancers

The FDA has granted approval to a new drug application (NDA) for 200-mg/mL vials of cyclophosphamide injection for use in combination therapy for the treatment of patients with various types of cancers, including malignant lymphoma, multiple myeloma, and various types of leukemia, according to Nevakar Injectables Inc.¹

“We are delighted to receive FDA approval and believe that cyclophosphamide ready-to-dilute multidose injection serves a very important need in oncology therapy,” said Sriram Ramanathan, MS, MBA, chief executive officer of Nevakar Injectables, in a press release. “The product is available in two configurations, 500 mg/2.5 mL and 1 g/5 mL vials, to provide the healthcare providers with flexibility to use based on patient needs.”

Previously, only solid formulations of cyclophosphamide were previously commercially available, according to a patent for stable liquid formulations of cyclophosphamide.²

Cyclophosphamide is biologically transformed in the liver and activates alkylating metabolites by a mixed function microsomal oxidase system. The agent involves the cross-linking of tumor cell DNA.

Though cyclophosphamide is effective alone in susceptible malignancies, it is more frequently used concurrently or sequentially with other antineoplastic drugs.

Cyclophosphamide injection can be used for the treatment of various malignancies, including Ann Arbor stage III and IV malignant lymphomas, Hodgkin lymphoma, nodular or diffuse lymphocytic lymphoma, mixed-cell–type lymphoma, Burkitt lymphoma, multiple myeloma, leukemias, chronic lymphocytic leukemia, chronic granulocytic leukemia, acute myelogenous and monocytic leukemia, acute lymphoblastic leukemia in pediatric patients, advanced mycosis fungoides, disseminated neuroblastoma, ovarian adenocarcinoma, retinoblastoma, and breast carcinoma.

“Our simple and elegant formulation contains no unnecessary additives and benefits both providers and patients, as it minimizes waste, is easy to prepare, and reduces the risk of dosing error and product exposure. This is Nevakar’s third NDA approval in the past year, highlighting our rapid pace of innovation, scalability, experience, and commitment to developing products that add value to the health-care system,” added Ramanathan in the press release.¹

References

1. Nevakar Injectables announces FDA approval of cyclophosphamide RTD solution. News release. Nevakar Injectables. July 3, 2023. Accessed July 5, 2023. https://tinyurl.com/9374wurf

2. United States patent US 11,382,923 B2. July 12, 2022. Accessed July 5, 2023. https://tinyurl.com/2c68wamd