FDA Expands Indication for Pemfexy to Include Subset of Advanced Non-Small Cell Lung Cancer

The Food and Drug Administration (FDA) approved an additional indication of Pemfexy (pemetrexed injection) to include the initial treatment of patients with metastatic, non-squamous, non-small cell lung cancer with no ALK or EGFR genomic tumor mutations.

In particular, Pemfexy is used in combination with Keytruda (pembrolizumab) and platinum chemotherapy to treat patients. Pemfexy was developed by Eagle Pharmaceuticals as a ready-to-dilute intravenous formulation to eliminate a step called reconstitution, or the process of adding a liquid dilutant to a dry ingredient to create a specific liquid concentration.

“With this fifth indication, Pemfexy is now approved for all of the same indications as Alimta (pemetrexed), 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 press release from the company. “We are pleased to bring this treatment option to patients undergoing chemotherapy.”

Pemfexy was first approved by the FDA in February 2020 for the treatment of advanced/metastatic non-squamous non-small cell lung cancer. With the addition of this approved indication, this marks the fifth indication for Pemfexy, according to the release. Of note, it is also indicated for the treatment of patients with mesothelioma.

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