The FDA is in charge of approving new treatments or devices for all diseases. For many years there were no approved treatments for malignant mesothelioma. Then in 2004, Pemetrexted and Cisplatin were approved by the FDA. In 2019, a new treatment called Tumor Treating Fields for malignant pleural mesothelioma was approved. NovaTTF100L therapy uses electric fields tuned to specific frequencies to disrupt solid cancer tumors. It is a non invasive therapy. The Nova TTF therapy is used in combination with Pemetrexed and a platinum based chemotherapy as the first line treatment for malignant mesothelioma.
This past week the Federal Drug Administration approved pemetrexed injection for patients with malignant mesothelioma. The injectable version will not be available until February 1, 2022 and is called Pemfexy. It will be available through Eagle Pharmaceuticals based in New Jersey.
Pemetrexted is the generic name for Alimta. Alimta and Cisplatin are the only first line drugs approved for the treatment of malignant mesothelioma. Approved by the FDA in 2004 these medications have been proven to extend overall survival for patients with malignant mesothelioma. There is no second line of medications approved by the FDA.for progression of disease, at this point.
What does the approval of an injectable form of Pemetrexed mean?
There is no change in the indications for the drug. Pemetrexed along with cisplatin is indicated for the treatment of other cancers besides malignant mesothelioma. Some of the cancers that they are prescribed for are locally advanced or metastatic nonsquamous non-small cell lung cancer, locally advanced or metastatic nonsquamous cell lung cancer that has not progressed after four cycles of platinum-based first-line chemotherapy.
The approval of Pemfexy made by Eagle Pharmaceuticals actually occurred in 2018 but there were some patent issues with it. In a press release from 2017, when it was granted tentative FDA approval, Eagle Pharmaceuticals explained that “our formulation does not require reconstitution, reducing the potential for dosing error during mixing as well as the hazards of inhaling cytoxic vapors that can occur when handling the powder form of the drug during preparation.”
Currently the drug, Alimta, is supplied in a powdered version and must be reconstituted then injected into an IV bag. Once in the IV bag it is administered over 10 minutes intravenously on Day 1 of each 21 day cycle, followed by a two hour infusion of Cisplatin. Alimta, which is manufactured by Eli Lilly and Co, has annual U.S. sales of approximately 1.0 billion over the last 12 months.