www.fdanews.com/articles/195919-fda-approves-eagle-pharmaceuticals-lung-cancer-treatment
FDA Approves Eagle Pharmaceuticals’ Lung Cancer Treatment
February 18, 2020
The FDA approved Eagle Pharmaceuticals’ Pemfexy (pemetrexed for injection) for treating nonsquamous non-small cell lung cancer (NSCLC) patients alongside the chemo drug cisplatin.
The ready-to-dilute injection is approved for patients with locally advanced or metastatic nonsquamous NSCLC whose disease has not progressed after four cycles of platinum-based first-line chemo.
The agency approved Pemfexy in 2017 but faced market restrictions due to existing patents. Now, thanks to a settlement agreement between Eagle and Eli Lilly, the drug will be able to fully enter the market on April 1, 2022.