• Skip to primary navigation
  • Skip to main content
  • Skip to primary sidebar
  • Skip to footer

Drug Delivery Business

  • Clinical Trials
  • Research & Development
  • Drug-Device Combinations
  • FDA
  • Pharmaceuticals
  • Policy

Delcath's ChemoSat goes another round with the FDA

October 28, 2011 By drugdelivery

Delcath's ChemoSat system

Delcath Systems Inc.’s (NSDQ:DCTH) ChemoSat organ-targeting chemotherapy system will get a pre-new drug application meeting with the FDA mid-January 2012, the company announced this week.

The ChemoSat device uses a system of tubes to localize the delivery of toxic chemotherapy agents by isolating the targeted organ — in this case, the liver — from the rest of the body’s bloodstream.

"With the filing of our NDA by the end of the year, we would anticipate a six-month review and U.S. approval in mid-year 2012 for the indication of melanoma mets to the liver," CEO Eamonn Hobbs told MassDevice during an interview in June.

The FDA refused Delcath’s original NDA earlier this year over concerns that the information provided was insufficient for review, an the company "embarked on a monitoring program to go back to the patient records and mine hospitalization data that the FDA is specifically looking for," Hobbs told us.

Check out our interview with Delcath president & CEO Eamonn Hobbs from June, 2011.

The watchdog agency’s response came as a surprise, Hobbs told us, as clinical trials had been designed and conducted under a special FDA agreement.

"We conducted our Phase III trial under an SPA, a special protocol assessment, which is a formal agreement with the agency on all the facts and circumstances associated with the trial," Hobbs said. "They wanted additional hospital data that was not collected in the original case report forms that were approved as part of the SPA."

Delcath won CE Mark approval in the European Union in April, where the device is considered a Class III medical device.

"We got a very broad indication in our CE Mark that covers all liver cancers. That translates into about 95 percent of the world market opportunity outside the U.S," Hobbs said. "Since the market opportunities are so much bigger outside the U.S., if I had to choose between the two regulatory approvals, I would take the one we got, the CE Mark, far ahead of the FDA’s, from a commercial perspective."

Delcath shares were up 5 percent to $3.74 in mid-afternoon trading today. The New York-based company plans to unveil its third quarter earnings report in a conference call on Monday, Nov. 7.

Filed Under: Drug-Device Combinations Tagged With: Delcath Systems Inc.

IN CASE YOU MISSED IT

  • Senseonics stock is up on Q2 results
  • MedAlliance wins second FDA IDE nod for drug-coated balloon
  • Wells Fargo downgrades Tandem amid rise of automated insulin delivery competition
  • FDA approves first targeted infusion therapy for HER2-low breast cancer
  • Abbott, WeightWatchers partner on diabetes care

Primary Sidebar

MEDTECH 100 INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.
Need Drug Delivery Business News in a minute? We Deliver!
Drug Delivery Enewsletters get you caught up on all the mission critical news you need in med tech. Sign up today.

Signup for the newsletter

Footer

Drug Delivery Business News Logo

MassDevice Medical NETWORK

MassDevice
DeviceTalks
Medical Tubing & Extrusion
Medical Design & Outsourcing
MedTech100 Index
Drug Discovery & Development
Pharmaceutical Processing World
Medical Design Sourcing
R&D World

DRUG DELIVERY BUSINESS NEWS

Subscribe to Drug Delivery’s E-Newsletter
Advertise with us
About
Contact us
Privacy
Listen to our Weekly Podcasts
Add us on FacebookFollow us on TwitterConnect with us on LinkedIn

Copyright © 2022 · WTWH Media LLC and its licensors. All rights reserved.
The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media.

Advertise | Privacy Policy | RSS