FDA Approves Pemetrexed Injection for Nonsquamous NSCLC and Malignant Pleural Mesothelioma

The FDA has granted a final approval to pemetrexed for injection (Pemfexy), an alternative to standard pemetrexed (Alimta) for the treatment of patients with locally advanced or metastatic nonsquamous non—small cell lung cancer (NSCLC) and for those with malignant pleural mesothelioma.

Specifically, the indication for the new formulation is for use in combination with cisplatin for patients with locally advanced or metastatic nonsquamous NSCLC; locally advanced or metastatic nonsquamous NSCLC whose disease has not progressed after 4 cycles of platinum-based first-line chemotherapy, as maintenance treatment; locally advanced or metastatic nonsquamous NSCLC after prior chemotherapy as a single agent; and for patients with malignant pleural mesothelioma whose disease is unresectable or who are otherwise ineligible for curative surgery in combination with cisplatin.

“We are pleased to receive final approval from FDA and look forward to making Pemfexy available to the patients who can benefit,” Scott Tarriff, chief executive officer of Eagle Pharmaceuticals, the developer of pemetrexed for injection, stated in a press release. “Our initial market exclusivity for Pemfexy represents a significant opportunity for Eagle and builds on the successes of our expanding presence in the oncology space."

The pemetrexed injection is a ready-to-dilute formulation that received tentative approval from the FDA in 2017. The company stated that the agency concluded that the injection met all required quality, safety and efficacy standards. However, at the time, the product was not eligible for marketing in the United States due to existing patent protections.

The approval follows a settlement agreement reached between Eagle Pharmaceuticals and Eli Lilly and Company, the latter of which manufactures standard pemetrexed.

“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,” Eagle Pharmaceuticals stated in the press release.

Eagle Pharmaceuticals receives final FDA approval for Pemfexy (pemetrexed for injection) [news release]: Woodcliff Lake, NJ. Eagle Pharmaceuticals. Published February 10, 2020. https://bit.ly/2SircfX. Accessed February 10, 2020.