The U.S. Food and Drug Administration (FDA) recently granted final approval of a new brand of a chemotherapy drug already in use by oncologists to treat malignant pleural mesothelioma and advanced stage non small cell lung cancer. Starting in February 2020, doctors will be allowed to prescribe Pemfexy, a type of chemotherapy drug called pemetrexed, and provide an alternative treatment to the name brand drug Alimta.
The new chemotherapy works as an injection, which is combined with cisplatin for patients with malignant pleural mesothelioma whose disease is unresectable or who are otherwise ineligible for curative surgery in combination with cisplatin. This new type of pemetrexed injection was already tentatively approved for use by the FDA in 2017 after the agency determined that the drug met all required quality, safety, and efficacy standards.
However, patients in the United States were not eligible to receive the treatment because the company that holds the patent for the standard pemetrexed treatment held patent protections on the product. Now, with a settlement agreement between the two sides, Eagle pharmaceuticals will be able to bring limited supplies of Pemfexy beginning in February 2020 and uncapped entry in April 2020.