FDA Grants Final Approval to Pemfexy For Advanced or Metastatic Nonsquamous NSCLC

The Food and Drug Administration (FDA) has given its final approval for the novel product Pemfexy (pemetrexed for injection), in combination with cisplatin, for the treatment of patients with nonsquamous non-small cell lung cancer (NSCLC).

Pemfexy is a liquid chemotherapy injection and branded alternative to another chemotherapy injection Alimta (pemetrexed). The ready to dilute formulation is meant for the treatment of locally advanced or metastatic nonsquamous NSCLC in combination with cisplatin chemotherapy as either a combination therapy, maintenance therapy after four cycles of progression free chemotherapy, and after prior chemotherapy as a single agent — depending on the patient’s diagnosis and treatment plan.

“We are pleased to receive final approval from FDA and look forward to making Pemfexy available to the patients who can benefit,” stated Scott Tarriff, chief executive officer of Eagle Pharmaceuticals, in a press release. “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.”

Eagle Pharmaceuticals, the manufacturer behind Pemfexy, developed the injectable to address shortcomings among other injectable products for the treatment of patients with cancer. Initially, the company received tentative approval from the FDA for Pemfexy but while the drug had met the FDA’s approval standards the drug was not allowed to be marketed in the US due to existing patent protections.

The final FDA approval comes off the heels of Eagle’s settlement agreement with Eli Lilly to allow for Pemfexy’s initial release into the market by Feb. 1, 2022.

Check back later for what you need to know about this approval.