Alternating electric field therapy

FDA Approves the NovoTTF-100LTM System in Combination with Chemotherapy for the Treatment of Malignant Pleural Mesothelioma

Retrieved on: 
Thursday, May 23, 2019
Health, Biotechnology, Clinical trials, Medical devices, Oncology, Pharmaceutical, Research, FDA, Science, General Health, Cancer, Clinical medicine, Medicine, RTT, Cancer treatments, Oncology, Antifolates, Eli Lilly and Company, Pemetrexed, Mesothelioma, Alternating electric field therapy, Glioblastoma

Prior to the FDA approval of NovoTTF-100L, pemetrexed plus cisplatin was the only FDA-approved therapy for patients with unresectable MPM.

Key Points: 
  • Prior to the FDA approval of NovoTTF-100L, pemetrexed plus cisplatin was the only FDA-approved therapy for patients with unresectable MPM.
  • The FDA approved Optune, another Tumor Treating Fields delivery system, under the Premarket Authorization (PMA) pathway in 2011 for the treatment of glioblastoma (GBM).
  • Authorized by Federal Law for use in the treatment of adult patients with unresectable, locally advanced or metastatic, malignant pleural mesothelioma concurrently with pemetrexed and platinum based chemotherapy.
  • Novocures commercialized products are approved for the treatment of adult patients with glioblastoma and malignant pleural mesothelioma.

Medicare Issues Proposed Local Coverage Determination that Provides Coverage of Optune® for Newly Diagnosed Glioblastoma

Retrieved on: 
Friday, May 10, 2019
Health, Biotechnology, Pharmaceutical, Professional services, Insurance, Medicine, Cancer, Clinical medicine, Brain tumor, Alternating electric field therapy, Medicare, Glioblastoma, GBM

Novocure (NASDAQ: NVCR) today announced the Medicare durable medical equipment (DME) Medicare Administrative Contractors (MACs) have issued a proposed local coverage determination (LCD ) that provides coverage of Tumor Treating Fields, or Optune, for newly diagnosed glioblastoma (GBM).

Key Points: 
  • Novocure (NASDAQ: NVCR) today announced the Medicare durable medical equipment (DME) Medicare Administrative Contractors (MACs) have issued a proposed local coverage determination (LCD ) that provides coverage of Tumor Treating Fields, or Optune, for newly diagnosed glioblastoma (GBM).
  • The coverage policy criteria proposed by the DME MACs is generally similar to Optunes commercial coverage criteria for newly diagnosed glioblastoma (GBM) with the exception of a proposed restriction on beneficiary site of care.
  • We view the proposed LCD as a positive step forward in a multi-step process, said Bill Doyle, Novocures Executive Chairman.
  • We have concerns, which we will share directly with the DME MACs, with the proposed limitations on where patients can access Optune.

Novocure Announces the International Journal of Radiation Oncology, Biology, Physics Publishes Data Demonstrating Higher Doses of Tumor Treating Fields Improved Survival of Newly Diagnosed Glioblastoma Patients

Retrieved on: 
Tuesday, April 30, 2019
Health, Biotechnology, Oncology, Pharmaceutical, Radiology, Research, Other Science, Science, General Health, Medicine, Clinical medicine, Cancer, Cancer treatments, Brain tumor, RTT, Oncology, Glioblastoma, Alternating electric field therapy, Temozolomide, Radiation therapy, Oligodendroglioma

Novocure (NASDAQ:NVCR) announced today that the International Journal of Radiation Oncology, Biology, Physics, known in the field as the Red Journal, has published the results of an EF-14 post-hoc analysis demonstrating that higher doses of Tumor Treating Fields improved survival in newly diagnosed glioblastoma (GBM) patients.

Key Points: 
  • Novocure (NASDAQ:NVCR) announced today that the International Journal of Radiation Oncology, Biology, Physics, known in the field as the Red Journal, has published the results of an EF-14 post-hoc analysis demonstrating that higher doses of Tumor Treating Fields improved survival in newly diagnosed glioblastoma (GBM) patients.
  • This analysis provides radiation oncologists with a better understanding of the relationship between Tumor Treating Fields dose and survival, and can be used to help optimize outcomes for GBM patients.
  • The simulation-based, post-hoc analysis included 340 patients from the EF-14 phase 3 pivotal trial, which compared Tumor Treating Fields plus temozolomide versus temozolomide alone for the treatment of newly diagnosed GBM.
  • Tumor Treating Fields is a cancer therapy that uses electric fields tuned to specific frequencies to disrupt solid tumor cancer cell division.