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Drug for Mesothelioma: Pemfexy Coming to the United States

Drug for Mesothelioma- Pemfexy

A new brand of pemetrexed is on its way to the United States for use in mesothelioma. The drug, sold under the brand name Pemfexy, is an alternative to Alimta, the only other brand of pemetrexed, a drug for mesothelioma, available at this time.

What is Pemetrexed?

Pemetrexed is a drug for mesothelioma. Although not used on its own, it is successful in fighting cancer when used with other cancer drugs, specifically cisplatin and carboplatin. Pemetrexed is in a drug class called antimetabolites and impacts the body’s use of folate. Folate is important for cancer cells, which need it to replicate. Pemetrexed helps fight cancer by stopping chemical reactions in the body involving folate.

Because the body still needs folate, however, doctors recommend starting folate and Vitamin B12 supplements a week before starting pemetrexed. This gives the body the folate and Vitamin B12 it needs to function, while still letting pemetrexed work to fight cancer at the cellular level.

How Will Pemfexy Be Used?

Standard chemotherapy for mesothelioma is a combination of pemetrexed and either cisplatin or carboplatin. To date, the only pemetrexed available in the United States has been sold under the brand name Alimta. This drug, developed by Eli Lilly and Company, was approved by the FDA in 2004 and has been the only option for patients as a drug for mesothelioma. An alternative brand, Pemfexy, was developed by Eagle Pharmaceuticals and tentatively approved by the FDA in 2017. However, due to Eli Lilly and Company’s patent on Alimta, Pemfexy was unable to be sold in the United States.

The dosing of Pemfexy is similar to that of Alimta. In people with good kidney function, Pemfexy can be given intravenously at a dose of 500 mg/m2 on Day 1 of each 21-day cycle with cisplatin. People starting Pemfexy should start to take folic acid 400 mcg to 1000 mcg daily a week before starting Pemfexy and should continue until 21 days after the last dose of Pemfexy. Further, vitamin B12 injections are recommended starting a week before the first dose of Pemfexy and should be repeated every 3 cycles. Dexamethasone 4 mg twice daily should also be given the day before, the day of, and the day after Pemfexy is given.

How are Pemfexy and Alimta Different?

Although Pemfexy and Alimta are both forms of pemetrexed, and therefore are the same drug for mesothelioma, there are differences in formulation between the two. Specifically, Pemfexy comes as a liquid while Alimta is a powder. Because they are chemically the same, the FDA has approved them both as the same drug. However, because of their different formulations, people who have trouble tolerating Alimta will have a new option with Pemfexy.

How Pemfexy May Help as a Drug for Mesothelioma

Having Pemfexy available as an alternative to Alimta may help people with mesothelioma in several different ways. First, the availability of two pemetrexed brands may help to lower treatment costs due to competition. Second, if a person is unable to tolerate Alimta, they may be able to tolerate Pemfexy. Third, because Pemfexy comes in a liquid form, while Alimta comes in a powder form that needs to be mixed, Pemfexy may help prevent errors during the medication preparation process.

When Will Pemfexy be Available?

An agreement with Eli Lilly and Company was formed in December 2019, however, paves the way for Pemfexy to be available in the United States starting in February 2022 as a drug for mesothelioma.

References:

https://investor.eagleus.com/press-release/eagle-pharmaceuticals-receives-final-fda-approval-pemfexy-pemetrexed-injectionhttps://www.accessdata.fda.gov/drugsatfda_docs/label/2020/209472s000lbl.pdf

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