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

Drug Delivery Business

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

FDA approves Novocure’s NovoTTF-100LTM plus chemo for mesothelioma

May 24, 2019 By Danielle Kirsh

novocure-logoNovoCure (NSDQ:NVCR) announced that it has received FDA approval for its NovoTTF-100L system with chemotherapy for treating a type of mesothelioma.

NovoTTF-100L is a non-invasive, antimitotic cancer treatment designed to deliver electric fields at special frequencies to disrupt solid tumor cancer cell division.

Approved under a humanitarian device exemption, NovoTTF-100L and pemetrexed plus platinum-based chemotherapyis indicated for the treatment unresectable, locally advanced or metastatic, malignant pleural mesothelioma, the company said.

“Since 2000, we have been developing and commercializing Tumor Treating Fields to extend survivals in some of the most aggressive forms of cancer,” chairman Bill Doyle said in a press release. “FDA approval of NovoTTF-100L provides patients with the first FDA-approved treatment for MPM in more than 15 years and, as our first FDA-approved torso cancer indication, marks a major milestone for Novocure. We are thankful for the patients, caregivers and healthcare providers who partnered with us to make this possible.”

Novocure said that preclinical data showed that mesothelioma cells were “highly sensitive” to the system’s tumor treating field. In its Stellar registration trial, 80 unresectable malignant pleural mesothelioma patients were treated with the tumor treating fields from the system and chemotherapy. There was a median overall survival of 18.2 months following treatment.

“MPM is a devastating disease, with only 10% to 20% of patients being candidates for surgery to remove the tumor,” Mary Hesdorffer, executive director of the Mesothelioma Applied Research Foundation, said. “Typically, mesothelioma patients who cannot have surgery receive palliative care to mitigate their symptoms. NovoTTF-100L provides unresectable MPM patients with a treatment option that may improve survival. We are encouraged by the FDA approval and hope it is just the beginning of innovation in the treatment of this aggressive disease.”

Filed Under: Oncology, Radiosurgery, Regulatory/Compliance Tagged With: NovoCure

IN CASE YOU MISSED IT

  • Flat Medical partners with Mercury Medical on smart syringe distribution
  • Glucotrack to effect a reverse stock split
  • Medtronic unveils ‘MiniMed’ as name for soon-to-be separated Diabetes unit
  • Insulet, Marvel collab to unveil comic book hero with type 1 diabetes
  • Insulet rolls out new Omnipod 5 iPhone app for use with Dexcom G7

About Danielle Kirsh

Danielle Kirsh is an award-winning journalist and senior editor for Medical Design & Outsourcing, MassDevice, and Medical Tubing + Extrusion, and the founder of Women in Medtech and lead editor for Big 100. She received her bachelor's degree in broadcast journalism and mass communication from Norfolk State University and is pursuing her master's in global strategic communications at the University of Florida. You can connect with her on Twitter and LinkedIn, or email her at dkirsh@wtwhmedia.com.

Primary Sidebar

“ddb
EXPAND YOUR KNOWLEDGE AND STAY CONNECTED
Get the latest news and trends happening now in drug delivery.

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.

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

Copyright © 2025 · 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.

Privacy Policy | RSS