publication date: Feb. 14, 2020

Drugs & Targets

FDA approves Pemfexy injection for lung cancer

FDA has granted approval Pemfexy, a pemetrexed injection ready-to-dilute formulation for locally advanced or metastatic nonsquamous non-small cell lung cancer in combination with cisplatin and other indications.

Pemfexy is also used to treat 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.

Eagle Pharmaceuticals sponsors Pemfexy, a branded alternative to Alimta.

The conversion from tentative to a final approval follows Eagle Pharmaceuticals’ settlement agreement reached with Eli Lilly and Co. on Dec. 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 Feb. 1, 2022, and a subsequent uncapped entry on April 1, 2022.

Eagle Pharmaceuticals 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.

 

FDA grants Priority Review for BMS agent lisocabtagene maraleucel

Bristol-Myers Squibb Co. said FDA has accepted for Priority Review its Biologics License Application for lisocabtagene maraleucel (liso-cel), the company’s autologous anti-CD19 CAR T-cell immunotherapy with a defined composition of purified CD8+ and CD4+ CAR T cells for the treatment of … Continue reading FDA approves Pemfexy injection for lung cancer

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