Pemetrexed Injection Receives FDA Approval for Fifth Indication in NSCLC Treatment


The additional indication expands its therapeutic role beyond advanced non-small cell lung cancer.

The FDA just approved pemetrexed injection (Pemfexy®; Eagle Pharmaceuticals, Inc.) to treat metastatic, non-squamous non-small cell lung cancer (NSCLC) and mesothelioma in combination with pembrolizumab and platinum chemotherapy, according to a press release.1 The approval is the fifth indication approved by the FDA over the past 2 years for the treatment of NSCLC without EGFR or ALK genomic tumor aberrations.1

“With this fifth indication, PEMFEXY is now approved for all of the same indications as [pemetrexed (Alimta, Eli Lilly and Company)] and we believe it allows for key advantages such as eliminating the need for reconstitution,” said Scott Tarriff, President, and chief executive officer of Eagle Pharmaceuticals, in a recent press release.1

The pharmaceutical company paid Eli Lilly a 1-time settlement of $15 million to amend profit rights—in exchange for the settlement, Eli Lilly would receive a lower percent on royalties from pemetrexed injection’s aggregate profits.1

Royalties on the pemetrexed injection will be reduced from 25% to a possible 0%. However, the amendment could allow for the company to receive up to 12.5% of aggregate profits. This amendment for pemetrexed injection was enacted on October 1, 2022.1

Pemetrexed injection is a ready-to-dilute (RTD) novel liquid intravenous formulation that eliminates the reconstitution step of Eli Lilly’s Alimta lung cancer therapy, which was first approved in 2004.2

Pemetrexed injection was previously indicated for:

  • Locally advanced or metastatic non-squamous NSCLC when combined with cisplatin.
  • Maintenance treatment in patients with non-progressing locally advanced or metastatic non-squamous NSCLC.
  • Patients with locally advanced or metastatic NSCLC who received single-agent chemotherapy.
  • Certain patients with malignant pleural mesothelioma.2

Eagle Pharmaceuticals was in a patent litigation with Eli Lilly and Company until reaching a settlement in December 2019. Two months after their settled agreement—in which Eli Lilly relinquished claims to the drug and pemetrexed injection was allowed to enter the market— Eagle Pharmaceuticals’ New Drug Application (NDA) was approved by the FDA in February of 2020.1

“Since its initial launch in February 2022, [pemetrexed 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,” Tarriff stated.1

The new pemetrexed injection is a branded alternative to Alimta. Despite sales having slowed in the past 5 years, with 2021 numbers down by $1.1 billion compared to those in 2016, Alimta’s 2021 sales are valued at $1.2 billion, and they made $119 million in quarter 3 alone.2

“We…believe that Eagle is well positioned to capture the commercial opportunity that [pemetrexed injection] represents,” Tarriff said in the press release.1


  1. Eagle Pharmaceuticals, Inc. Eagle Pharmaceuticals Receives FDA Approval for Additional Indication for PEMFEXY® in Combination with Pembrolizumab and Platinum Chemotherapy. News Rleae. Decemer 19, 2022. Accessed on Decmeber 19, 2022.
  2. Dunleavy K. With another FDA nod, Eagle's Pemfexy gets up to speed with Lilly's Alimta. Fierce Pharma. News Release. December 19, 2022. Accessed on December 19, 2022.
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