New Delhi: The US Food and Drug Administration has placed a clinical hold on iovance Biotherapeutics’ lung cancer therapy trial after a patient death, the company said on Wednesday.
Shares of Iovance were down 26.9 per cent in premarket trading.
The death was potentially related to a pre-conditioning regimen, where the patient receives a short course of chemotherapy to kill immune cells before being infused with Iovance’s LN-145. TILL therapy, the company said.
The company will pause enrollment in the non-small cell lung cancer trial during the hold, while patients who were previously treated with the therapy will continue to be monitored.
Non-small cell lung cancer accounts for more than 80 percent of all lung cancers, making it the most common type.
The company said that it will work with the FDA to safely resume enrollment as soon as possible.
The clinical hold has no impact on any other trials conducted by the company, Iovance said.
The company is currently awaiting the FDA’s decision on its experimental cell therapy lifileucel to treat a type of skin cancer called advanced melanoma.
The FDA had extended review of its skin cancer therapy from November this year to Feb. 2024, due to resource constraints.
