FDA gives final approval for Pemfexy in non-small cell lung cancer and pleural mesothelioma.- Eagle Pharma

Eagle Pharmaceuticals announced that it has received final approval from the FDA for its novel product, Pemfexy (pemetrexed for injection), a branded alternative to Alimta. The drug is now finally approved for locally advanced or metastatic nonsquamous non-small cell lung cancer in combination with cisplatin; locally advanced or metastatic nonsquamous non-small cell lung cancer whose disease has not progressed after four cycles of platinum-based first-line chemotherapy, as maintenance treatment; locally advanced or metastatic nonsquamous non-small cell lung cancer after prior chemotherapy as a single agent; and malignant pleural mesothelioma whose disease is unresectable or who are otherwise not candidates for curative surgery in combination with cisplatin. The conversion from tentative to a final approval follows the Company’s settlement agreement reached with Eli Lilly and Company on December 13, 2019. This agreement provides for a release of all claims by the parties and allows for an initial entry of Pemfexy into the market (equivalent to approximately a three-week supply of current Alimta utilization) on February 1, 2022, and a subsequent uncapped entry on April 1, 2022. The Company received tentative approval for Pemfexy in 2017, reflecting FDA’s conclusion that the product met all required quality, safety and efficacy standards, but at the time was not eligible for marketing in the U.S. because of existing patent protections.