New chemotherapy delivery method scores FDA orphan drug status
Renovorx device targets pancreatic cancer tumors with oxaliplatin
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The U.S. Food and Drug Administration (FDA) has granted orphan drug designation to an experimental delivery method for the chemotherapy oxaliplatin as a potential treatment for pancreatic cancer.
The FDA gives this designation to investigational treatments targeting rare diseases, defined as conditions affecting fewer than 200,000 people in the U.S. The goal is to provide economic incentives for companies investing in treatments for rare diseases, which by definition have a small market that can make it hard to recoup development costs and turn a profit.
The designation gives the device’s maker, Renovorx, seven years of market exclusivity if the therapy is ultimately approved by the FDA. The company will also get regulatory incentives including “a waiver of FDA application fees that can total several million dollars,” Shaun Bagai, CEO of Renovorx, said in a company press release.
The designation “is an important milestone as it provides additional validation of our strategy to build a multi-agent, targeted, drug-delivery oncology pipeline enabled by our patented RenovoCath device,” Bagai said.
Oxaliplatin is approved as part of various treatment regimens for many types of cancer. It is a component of FOLFIRINOX, a chemo regimen commonly used to help treat pancreatic cancer.
Specialized catheter targets blood vessels near tumors
Traditionally, chemotherapy agents like oxaliplatin are administered intravenously, by infusion into the bloodstream. Since blood circulates throughout the body, it can effectively deliver medications to the site of a tumor — but it’s not very efficient, and circulating cell-killing chemotherapy can lead to an array of side effects.
Renovorx’s RenovoCath device includes a specialized catheter (a small, thin tube) designed to be inserted into a specific blood vessel. The device contains two balloons, one at each end, that can block blood flow in and out of the selected blood vessel. Medications such as oxaliplatin can then be administered into the blocked blood vessel. The basic idea is that, rather than delivering a medication to all the blood in the body, it would be specifically delivered to vessels near the tumor, allowing more efficient delivery and minimizing side effects. This type of administration is known as intra-arterial delivery.
“This designation for intra-arterial oxaliplatin highlights the breadth of what RenovoCath may offer to pancreatic cancer patients,” said Leesa Gentry, chief clinical officer at Renovorx.
The FDA previously granted orphan drug designations for the RenovoCath device to deliver another chemotherapy agent, gemcitabine, in people with locally advanced pancreatic cancer (LAPC) and bile duct cancer.
“Intra-arterial oxaliplatin may broaden the range of pancreatic cancer targets beyond LAPC that could benefit from localized drug-delivery with RenovoCath,” Gentry said.
