The injection is a ready-to-dilute formulation indicated for the following:
- locally advanced or metastatic nonsquamous NSCLC in combination with cisplatin
- locally advanced or metastatic nonsquamous NSCLC whose disease has not progressed after 4 cycles of platinum-based first-line chemotherapy, as maintenance treatment
- locally advanced or metastatic nonsquamous NSCLC after prior chemotherapy as a single agent
- malignant pleural mesothelioma whose disease is unresectable or who are otherwise not candidates for curative surgery in combination with cisplatin
This conversion from tentative approval—granted in 2017, but at the time was not eligible for marketing in the U.S. because of existing patent protections—to final approval is followed by the company’s settlement agreement with Eli Lilly and Company, which allowed for the initial entry of pemetrexed for injection into the market on February 1, 2022, and a subsequent uncapped entry on April 1, 2022.
“We are pleased to receive final approval from (the) FDA and look forward to making Pemfexy available to the patients who can benefit. Our initial market exclusivity for PEMFEXY represents a significant opportunity for Eagle and builds on the successes of our expanding presence in the oncology space,” Scott Tarriff, chief executive officer of Eagle Pharmaceuticals, said in a press release.
With full approval, Eagle Pharmaceuticals has exclusive rights to commercialize the product for 4 months beginning February 1, 2022.