FDA Approves Additional Indication for Pemetrexed Injection Plus Pembrolizumab/Chemo in Metastatic NSCLC

The FDA has approved an additional indication for pemetrexed injection plus pembrolizumab and chemotherapy in the treatment of metastatic non–small cell lung cancer without EGFR or ALK tumor aberrations.

Patients with metastatic, non-squamous, non-small cell lung cancer (NSCLC) harboring no EGFR or ALK tumor aberrations can now receive a pemetrexed injection (Pemfexy) with pembrolizumab (Keytruda) and platinum-based chemotherapy per the FDA’s approval, according to a press release from Eagle Pharmaceuticals.1

This represents the fifth indication for the approved pemetrexed injection, a ready-to-dilute novel liquid intravenous formulation designed to eliminate the reconstitution step of the listed drug, pemetrexed (Alimta).

“With this fifth indication, [pemetrexed injection] 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,” Scott Tariff, president and chief executive officer of Eagle Pharmaceuticals, said in the press release.

The pemetrexed injection was originally approved in February 2020 by the FDA for the treatment of patients with non-squamous NSCLC.2 It was indicated for use in this patient population in combination with cisplatin, for those whose disease has not progressed after 4 prior lines of chemotherapy, after chemotherapy as a single agent, and as treatment for unresectable mesothelioma.


  1. Eagle Pharmaceuticals receives FDA approval for additional indication for PEMFEXY® in combination with pembrolizumab and platinum chemotherapy. News release. Eagle Pharmaceuticals. December 19, 2022. Accessed December 19, 2022. bit.ly/3G4NQBp
  2. Eagle Pharmaceuticals receives final FDA approval for Pemfexy™ (pemetrexed for injection). News release. Eagle Pharmaceuticals. February 10, 2020. Accessed December 19, 2022. bwnews.pr/3uZ09bU

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