FDA Expands Approval of Pemetrexed Injection for Metastatic NSCLC Without EGFR/ALK Aberrations

The FDA has approved an additional indication for pemetrexed by injection (Pemfexy), an alternative to standard pemetrexed (Alimta), in combination with pembrolizumab (Keytruda) and platinum-based chemotherapy for the initial treatment of patients with metastatic, nonsquamous non–small cell lung cancer (NSCLC) without EGFR or ALK genomic tumor aberrations.¹

In February 2020, the regulatory agency approved pemetrexed for injection in combination with cisplatin for patients with locally advanced or metastatic nonsquamous NSCLC; as maintenance treatment for locally advanced or metastatic nonsquamous NSCLC that has not progressed after 4 cycles of platinum-based first-line chemotherapy, 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.²

“With this fifth indication, [pemetrexed for injection] is now approved for all of the same indications as [standard pemetrexed], and we believe it allows for key advantages such as eliminating the need for reconstitution,” Scott Tarriff, president and chief executive officer of Eagle Pharmaceuticals, stated in a press release.

“Since its initial launch in February 2022, [pemetrexed for injection] has been an important addition to Eagle’s hospital and acute care product portfolio, and we are pleased to bring this treatment option to patients undergoing chemotherapy. At the same time, we also believe that Eagle is well positioned to capture the commercial opportunity that [pemetrexed for injection] represents.”

Pemetrexed for injection is a ready-to-dilute novel liquid intravenous formulation developed to eliminate the reconstitution step of standard pemetrexed.

The February 2020 approval followed the settlement agreement of patent litigation between Eagle Pharmaceuticals and Eli Lilly and Company in December 2019. The agreement provided for a release of all claims by the parties and allowed for an initial entry of pemetrexed for injection into the market on February 1, 2022, and a subsequent uncapped entry on April 1, 2022.

References

1. Eagle Pharmaceuticals receives FDA approval for additional indication for Pemfexy® in combination with pembrolizumab and platinum chemotherapy. News release. Eagle Pharmaceuticals, Inc. December 19, 2022. Accessed December 20, 2022. https://bit.ly/3FIUM5M
2. Eagle Pharmaceuticals receives final FDA approval for Pemfexy (pemetrexed for injection). News release. Eagle Pharmaceuticals, Inc. February 10, 2020. Accessed December 20, 2022. https://bit.ly/3WA24zm