Eagle Pharmaceuticals gets Pemfexy FDA approval for NSCLC

Eagle Pharmaceuticals has secured an additional indication for Pemfexy (pemetrexed injection) in the US, marking the fifth indication for the intravenous medication.

Pemfexy in combination with Merck’s Keytruda and platinum chemotherapy has been now approved by the US Food and Drug Administration (FDA) for the initial treatment of patients with metastatic, non-squamous, non-small cell lung cancer (NSCLC) with no EGFR or ALK genomic tumor aberrations.

The Pemetrexed injection is a ready-to-dilute liquid intravenous designed to remove the reconstitution step of the listed drug Alimta, an anti-cancer drug developed by Eli Lilly and Company (Lilly).

Scott Tarriff — Eagle Pharmaceuticals President and CEO said: “With this fifth indication, Pemfexy is now approved for all of the same indications as Alimta, and we believe it allows for key advantages such as eliminating the need for reconstitution.

“Since its initial launch in February 2022, PEMFEXY 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 PEMFEXY represents.”

In February 2020, Eagle Pharmaceuticals received approval from the FDA of its new drug application (NDA) for Pemfexy, with the settlement agreement of patent litigation with Lilly in December 2019.

Eagle Pharmaceuticals paid Lilly a one-time payment of $15 million to reduce future royalties related to Pemfexy profits from 25% to a range of 0% to 12.5% in exchange of the settlement.