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.