Eagle receives FDA nod for new indication for Pemfexy

The additional indication is for the initial treatment of patients with metastatic, non-squamous, non-small cell lung cancer with no EGFR or ALK genomic tumor aberrations.
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Eagle has obtained the Food and Drug Administration’s clearance for an additional indication for Pemfexy (pemetrexed injection) in combination with pembrolizumab and platinum chemotherapy for the initial treatment of patients with metastatic, non-squamous, non-small cell lung cancer with no EGFR or ALK genomic tumor aberrations. Eagle’s approved Pemfexy is a ready-to-dilute novel liquid intravenous formulation developed to eliminate the reconstitution step of Lilly's Alimta.

“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,” said Scott Tarriff, president and CEO of Eagle. “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.”

[Read more: Eagle receives FDA approval for generic Vasostrict

Effective Oct. 1, 2022, the company amended its agreement to reduce future royalties related to Pemfexy profits from 25% to a range of 0% to 12.5% based on aggregate profits achieved in exchange for a one-time payment of $15 million.

In February 2020, Eagle received approval from the FDA for its NDA for Pemfexy, following the settlement agreement of patent litigation with Eli Lilly in December 2019. The agreement provided for a release of all claims by the parties and allowed 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.

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