The Food and Drug Administration granted a final approval to pemfexy, a branded alternative chemotherapy injection for patients with advanced or metastatic nonsquamous non-small cell lung cancer, potentially offering them a cheaper treatment option in the future.
Recently, the Food and Drug Administration (FDA) gave final approval to the novel product Pemfexy (pemetrexed for injection) for the treatment of patients with advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC).
Pemfexy is a branded alternative chemotherapy injection to Alimta (pemetrexed) and 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, or after prior chemotherapy as a single agent. The ready to dilute formulation is meant to help oncology pharmacists make a patient’s chemotherapy the same way Alimta is, however, it is also meant to help reduce the cost of the treatment.
“Our ability to get to the market before any other form of Alimta is really exciting for us, but we plan on offering it at a discount to what (Altima) is selling for today,” explained Scott Tarriff, founder, CEO, and director of Eagle Pharmaceuticals, in an interview with CURE
. Eagle, the manufacturer behind Pemfexy, initially received a tentative approval from the FDA for Pemfexy in 2017 but the drug was not allowed to the market due to existing patent protections. The final approval from the FDA came after Eagle’s settlement agreement with Eli Lilly, the manufacturer behind Alimta, allowing Pemfexy’s initial release into the market by Feb. 1, 2022.
While Pemfexy shares Alimta’s benefits and side effects, it does not reduce the number of side effects patients with nonsquamous NSCLC might experience when taking chemotherapy as an injectable. However, the current product on the market is a powder that needs to be reconstituted by pharmacists, which can be a long process. Moreover, it has the potential for mistakes when making the treatment, whereas, Pemfexy is a liquid that eliminates that step for reconstitution, Tariff explained.
“I think hospitals, for the most part, across the country are getting much better at (reconstitution) over the years, but there are dosing errors that occur with these powders. And we made our product into liquid that doesn't require the same reconstitution,” he added. “So, in theory, we're going to have less mistakes at the pharmacy level, less mistakes being infused into a cancer patient.”
Tarriff explained that Pemfexy does not have a medical benefit over Alimta, but he hopes that it will allow patients to get out of the cancer center quicker and offer an option that could potentially cut down their price tag when undergoing treatment. Currently, the average price for a single injection of Alimta is $666 per dose, depending on the patient’s insurance plan.
“I think as the patient you should always ask, is there a better price alternative? Can I get the same quality treatment? Can I get the same outcome outcomes and not pay as much as I've been paying,” said Tarriff. “And in this particular case, when our product comes to the market, I hope that's exactly what patients are asking.”
Read CURE’s original coverage of Pemfexy’s final approval.