AXTLE (pemetrxed)

Pemetrexed (Alimta) was initially approved by the U.S. Food and Drug Administration (FDA) in February 2004 for use in combination with cisplatin for the treatment of malignant pleural mesothelioma in adults whose disease is unresectable or who are not otherwise candidates for curative surgery. The FDA has since approved pemetrexed as single agent therapy in locally advanced or metastatic non-small cell lung cancer following prior chemotherapy, for use in combination with cisplatin for first-line therapy in locally advanced or metastatic non-squamous non-small cell lung cancer, and for maintenance treatment of advanced or metastatic nonsquamous non-small cell lung cancer after first-line treatment with platinum-based chemotherapy. The agent received orphan drug status from the FDA for the malignant pleural mesothelioma. Pemetrexed acts as a multi-targeted antifolate compound that disrupts folate-dependent metabolic processes that are essential for cell replication. Mutltiple pemetrexed products are available that have been approved via the 505(b)(2) New Drug Application (NDA) process. They have different HCPCS codes are are not considered interchangeable. National Comprehensive Cancer Network (NCCN) Guidelines for Malignant Pleural Mesothelioma (Version 1.2022), Non-Small Cell Lung Cancer (Version 1.2022), Ovarian Cancer (Version 3.2021), Thymomas and Thymic Carcinomas (Version 1.2022), and Central Nervous System Cancers (Version 2.2021) include recommendations for use of pemetrexed. <a id="