FDA approves treatment for metastatic ocular melanoma
Hepzato receives approval for the treatment of ocular melanoma that has spread to the liver
18 August 2023
The US Food and Drug Administration has given approval for the Hepzato procedure to be used in patients with ocular melanoma that has spread to the liver.
Hepzato involves the use of a hepatic delivery system to inject the chemotherapy drug melphalan into the liver.
Dr Jonathan Zager, of Moffitt Cancer Center, led the Focus multinational phase three clinical trial to test the procedure.
“This is a breakthrough therapy that will help a patient population that has very few treatment options,” he said.
He added that the trial illustrated a very positive overall response rate to Hepzato and manageable levels of toxicity.
Around 90% of metastases in patients with ocular melanoma are sited solely or predominantly in the liver.
The clinical trial found that the response rate of tumours to therapy was three times higher among patients who received Hepzato compared to those who received the best alternative care options.
Zager shared his gratitude for the patients who took part in the clinical trial.
“This approval has been years in the making. I am grateful to have had the opportunity to be the lead principal investigator on the trial and super excited to offer this therapy to more patients with metastatic uveal melanoma,” he said.
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