The FDA has cleared injectable pemetrexed for mesothelioma after two drug companies settled a patent dispute over the medication in December.
Until now, the chemotherapy drug pemetrexed has only been available for infusion. In this form, it is called Alimta and is distributed by Eli Lilly.
But New Jersey-based Eagle Pharmaceuticals wanted to develop a form of injectable pemetrexed for mesothelioma. They received tentative approval for the drug in 2018, but it was not until the patent issue was settled that the final approval was granted.
The drug may shorten the duration of treatment for some patients with malignant mesothelioma.
Pemetrexed the Primary Mesothelioma Treatment
Malignant mesothelioma is an intractable cancer that grows on the membranes around internal organs. Patients diagnosed with this devastating disease do not usually live more than about a year after diagnosis.
Until last year, Alimta was the only FDA-approved treatment for malignant mesothelioma. Last year, an electrically-based external treatment called Tumor Treating Fields also won FDA approval for mesothelioma. Alimta was still the only approved drug.
In 2017, Eagle Pharmaceuticals tried to introduce injectable pemetrexed for mesothelioma. Eli Lilly argued that they held the patent for pemetrexed. This kept the injectable form, called Pemfexy, out of the US market.
On December 31, the two companies reached a settlement. This allowed the FDA to shift approval of injectable pemetrexed for mesothelioma from tentative to final. A limited supply of the drug was released on February 1. The full supply will be available April 1.
“We are pleased to receive final approval from FDA and look forward to making Pemfexy available to the patients who can benefit,” Eagle CEO Scott Tarriff said in a news 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.”
The Evolution of Pemetrexed
The development of injectable pemetrexed for mesothelioma has been an evolution.
The FDA approved Alimta as the first mesothelioma treatment in 2004. It’s approval was fast-tracked under the “compassionate use” provision because there were so few options for mesothelioma patients. Alimta’s developer was a chemistry professor from Princeton University. Dr. Edward Taylor worked on the formulation of pemetrexed for decades.
Today, Alimta, in combination with cisplatin, is the first-line mesothelioma treatment for most patients. It is also approved for non-small cell lung cancer treatment.
Injectable pemetrexed for mesothelioma is just the latest iteration of this life-saving drug. It is approved for mesothelioma patients who are not candidates for surgery, for whatever reason. It is also approved for certain patients with non-small cell lung cancer.
Pemetrexed is likely to continue to evolve. A group of scientists in India and Saudi Arabia are experimenting with an oral form of the drug.
Eagle Pharmaceuticals receives final FDA approval for Pemfexy (pemetrexed for injection), February 10, 2020, News Release, Eagle Pharmaceuticals, https://bit.ly/2SircfX
Soni, K, et al, “Development of pemetrexed diacid-loaded Gelatin-Cloisite 30B (MMT) nanocomposite for improved oral efficacy against cancer: Characterization, In-vitro and Ex-vivo Assessment”, February 10, 2020, Current Drug Delivery, Epub ahead of print, http://www.eurekaselect.com/179185/article