• 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 files new FDA application for chemo drug-device combination

August 16, 2012 By drugdelivery

Delcath chemo delivery illustration

Delcath Systems (NSDQ:DCTH) filed a new FDA application for the latest iteration of its ChemoSat drug-device combination, the Generation 2 device, in treatment of patients with non-operable liver cancer.

Delcath’s ChemoSat 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.

Delcath must seek new drug approval for the melphalan hydrochloride the ChemoSat system uses to destroy cancerous tissue.

"Our team has achieved a significant milestone with the filing of our NDA," president & CEO Eamonn Hobbs said in prepared remarks. "Based upon the strength of our Phase I, II and III data, along with the limited treatment options available for patients with unresectable melanoma metastases in the liver, we believe that our application meets the FDA’s criteria for priority review."

The FDA refused Delcath’s original NDA, filed last year, over concerns that the information provided was insufficient for review.

Check out our interview with Delcath president & CEO Eamonn Hobbs.

The watchdog agency’s response came as a surprise, Hobbs told MassDevice.com last year, 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 re-mined it clinical data for the information the FDA had asked for in preparation for a pre-review meeting for a 2nd round with the FDA.

The federal watchdog agency had previously granted Delcath 2 orphan drug designations for treatment in ocular and cutaneous melanoma, which will give the company exclusivity in those indications for 7 years if the NDA is approved.

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

IN CASE YOU MISSED IT

  • FDA approves first targeted infusion therapy for HER2-low breast cancer
  • Abbott, WeightWatchers partner on diabetes care
  • Insulet up on Q2 sales beat, raised full-year guidance
  • Aptar acquires Orbital dry powder inhaler license
  • Tandem sinks on Q2 misses, slashed sales guidance

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