Almost a decade after Delcath suffered an FDA rejection for its drug/device combo, the company has crossed the regulatory finish line in the U.S.
Monday, Delaware-based Delcath said the FDA approved Hepzato Kit as a liver-directed treatment for certain adult patients with metastatic uveal melanoma (mUM) with unresectable hepatic metastases.
Uveal melanoma is a rare cancer that strikes the eye, and for patients with mUM, the cancer has spread. Nearly all mUM cases—9 out of 10—involve the liver, according to Delcath. Liver failure is often a patient's cause of death.
Delcath's Hepzato Kit is a drug/device combo that administers the decades-old chemotherapy melphalan into the liver through a process called percutaneous hepatic perfusion, according to the company.
The "minimally invasive" process uses percutaneous catheters to temporarily isolate the liver from the rest of the body's circulatory system. Then, over the span of 30 minutes, the device administers melphalan hydrochloride directly to the liver.
A patient's blood then filters through the device's "proprietary filters," according to Delcath, and returns to the rest of the circulatory system.
The product won a CE mark in Europe in 2012 and is available there under the name Chemosat. The following year, the FDA rejected Delcath's application, telling the company to run at least one additional controlled trial to prove the med's benefits outweigh its risks.
Meanwhile, the National Comprehensive Cancer Network (NCCN) treatment guidelines already endorse the procedure utilized by Hepzato Kit.
With the approval, Delcath plans its commercial launch during the fourth quarter of 2023. In the meantime, the company plans to continue offering the treatment through its expanded access program.
Delcath's clinical program has also studied the product in colorectal cancer, neuroendocrine tumors and primary liver cancer.
The approval "marks the beginning of a new chapter for Delcath and the culmination" of the company's efforts to bring the treatment to patients, CEO Gerard Michel said in a statement.
"We look forward to partnering with cancer centers across the country to build a network of treatment sites trained in the use of this novel therapy," Michel added.
Delcath's stock price nearly doubled after the FDA approval and was trading at around $6.00 on Tuesday morning.