Alternative to Alimta Coming for Mesothelioma Patients

The U.S. Food and Drug Administration has granted final approval of Pemfexy, a new brand of the chemotherapy drug pemetrexed, to combat malignant mesothelioma and advanced stage non-small cell lung cancer.

The approval will allow oncologists to offer an alternative to Alimta, which today is considered standard pemetrexed and manufactured by Eli Lilly and Company. The chemotherapy drug is designed to block DNA replication and cell division.

However, Pemfexy will not be available until February 2022. The FDA approval is limited to pleural mesothelioma patients whose disease is unresectable.

Pemfexy is produced by Eagle Pharmaceuticals, a smaller company based in New Jersey. The drug is a ready-to-dilute formulation of pemetrexed that received tentative FDA approval in 2017.

Oncologists Dr. Bernardo Goulart at the Seattle Cancer Care Alliance and Dr. Jorge Gomez at Mount Sinai Hospital in New York told The Mesothelioma Center at Asbestos.com that the addition of Pemfexy could become a significant benefit for future patients.

“This is good news, not only for mesothelioma patients but for others, too,” Goulart said. “The competition may lower the price of the drug. And by lowering the price, it will increase patient access.”

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Drug Companies Battled over Patent Rights

Existing patent protections held by Eli Lilly have prevented Eagle Pharmaceuticals from marketing its product in the United States.

Lilly filed a lawsuit against Eagle Pharmaceuticals in September 2019 for infringing upon its patent of Alimta. A settlement of that lawsuit in December cleared the path for this final approval of Pemfexy.

Pemfexy is already is being used in other countries. As part of the settlement, Pemfexy will be available within the U.S. on a limited basis starting Feb. 1, 2022. Unlimited availability begins April 1, 2022.

Alimta Brings More Than $2B in Sales Each Year

Eli Lilly has reported sales of Alimta within the United States at more than $2 billion annually.

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

Tarriff told Reuters News Network that he expects the company to capture close to one-third of the market that Alimta currently holds.

Before the approval, generic competition to Alimta within the U.S. had been prohibited by the patent until May 2022.

The FDA first approved the use of Alimta for pleural mesothelioma in 2004, making it part of the standard-of care treatment of the cancer in combination with cisplatin, another chemotherapy drug.

Although it can kill mesothelioma tumor cells, its effectiveness often diminishes quickly, leading to proliferation of the cancer.

Lilly’s patent of Alimta was built around a vitamin regimen with which it was mixed that helped to reduce the drug’s toxicity and slow the reproduction of cancer cells.

Pemfexy has met all required safety, quality and efficacy standards.

Beyond lowering costs, another positive from the FDA approval is that Pemfexy arrives at cancer centers in liquid form, unlike Alimta, which is powder and requires reconstitution.

There is a higher risk for human error with the powder form, which could occur from using the wrong diluent or having the wrong concentration prior to dilution. By not requiring reconstitution, Pemfexy also minimizes the risk of exposure to a cytotoxic agent.

“It’s the same drug, but it might be a little bit safer,” Gomez said. “Anything that decreases the cost of treatment is beneficial.”

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