Iovance Biotherapeutics (IOVA) -) shares fell sharply in Wednesday trading after it said the Food and Drug Administration put a key lung-cancer-drug trial on hold following the death of a patient.
The FDA placed a clinical hold on the trial on Dec. 22, Iovance said, in response to a fatal event that could be linked to its developing therapy for non-small-cell lung cancer, known as LN-145 TIL.
Iovance said the death may have been linked to the so-called preconditioning regime a patient with this cancer, the most common form of lung cancer, must first undergo before they are then infused with LN-145.
The group said the FDA hold would have no impact on its other trials, adding that it would work with the agency to attempt to resume enrollment in the trial.
“Iovance remains dedicated to addressing a significant unmet medical need for patients with advanced [non-small-cell lung cancer], who have poor prognosis following disease progression and limited treatment options," said Friedrich Graf Finckenstein, Iovance's chief medical officer.
"We will work with the FDA to safely resume enrollment in the IOV-LUN-202 trial as soon as possible.”
Iovance shares at last check were marked 21% lower at $7.02 each. In 2023 through the close of trading Tuesday the shares had been up 39%.
The FDA is slated to rule on Iovance's developing Lifileucel drug, aimed at patients suffering from metastatic melanoma, a form of skin cancer, in February.
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