Market Overview

German Federal Joint Committee Announces Decision to Support a Clinical Trial to Study Optune® for the Treatment of Newly Diagnosed Glioblastoma


Proposed trial design will examine the benefit of combining Optune
with radiation therapy and temozolomide prior to the initiation of
maintenance temozolomide

Novocure (NASDAQ:NVCR) today announced that the German Federal Joint
Committee, (Gemeinsamer Bundesausschuss or G-BA), has published its
decision to support a clinical trial studying Optune for the treatment
of newly diagnosed glioblastoma (GBM).1 The proposed trial
design will examine the benefit of combining Optune with radiation
therapy and temozolomide prior to the initiation of maintenance
temozolomide in accordance with Section 137e of the German Healthcare
Provision Act. The G-BA decision is an important first step in
Novocure's process to secure national reimbursement for Optune in

The trial design as proposed would enroll 933 patients. Novocure and the
G-BA will share the costs for the conduct of the clinical trial. The
statutory health insurance funds will reimburse treatment costs,
including the cost of Optune for trial patients.

"The decision by the G-BA to study Optune in combination with radiation
therapy for the treatment of newly diagnosed GBM will provide valuable
data on the benefits of initiating therapy earlier in the course of GBM
treatment," said Eilon Kirson, Novocure's Chief Science Officer and Head
of Research and Development. "We are excited to understand the possible
impact of earlier initiation of Optune in newly diagnosed GBM and are
pleased to partner with the G-BA for this pivotal trial."

The positive decision to initiate a clinical trial does not imply
immediate funding. Before the trial can begin, the G-BA subcommittee for
assessment of new methods must issue a final directive for approval by
the German Ministry of Health. The German Ministry of Health approval
process and subsequent initiation of the clinical trial is anticipated
to take up to an additional 18 months, and could take longer. In the
interim, Novocure will continue to bill German healthcare payers for
individual cases. Each case is evaluated individually on its merits and
under the payer's specific rules for such cases.

1 G-BA decision available at:

Approved Indications

In the United States, Optune is intended as a treatment for adult
patients (22 years of age or older) with histologically-confirmed
glioblastoma multiforme (GBM).

In the United States, Optune with temozolomide is indicated for the
treatment of adult patients with newly diagnosed, supratentorial GBM
following maximal debulking surgery and completion of radiation therapy
together with concomitant standard of care chemotherapy.

In the United States, for the treatment of recurrent GBM, Optune is
indicated following histologically-or radiologically-confirmed
recurrence in the supratentorial region of the brain after receiving
chemotherapy. The device is intended to be used as a monotherapy, and is
intended as an alternative to standard medical therapy for GBM after
surgical and radiation options have been exhausted.

In Europe, Optune is intended for the treatment of patients with newly
diagnosed GBM, after surgery and radiotherapy with adjuvant
temozolomide, concomitant to maintenance temozolomide. The treatment is
intended for adult patients, 18 years of age or older, and should be
started more than 4 weeks after surgery and radiation therapy with
adjuvant temozolomide. Treatment may be given together with maintenance
temozolomide and after maintenance temozolomide is stopped.

In Europe, Optune is also intended for the treatment of patients with
recurrent GBM who have progressed after surgery, radiotherapy and
temozolomide treatment for their primary disease. The treatment is
intended for adult patients, 18 years of age or older, and should be
started more than 4 weeks after the latest surgery, radiation therapy or

Patients should only use Optune under the supervision of a physician
properly trained in use of the device. Full prescribing information is
available at
or by calling toll free 1-855-281-9301 in the US or by email at
in Europe.

About Novocure

Novocure is an oncology company developing a profoundly different cancer
treatment utilizing a proprietary therapy called TTFields, the use of
electric fields tuned to specific frequencies to disrupt solid tumor
cancer cell division. Novocure's commercialized product, Optune, is
approved for the treatment of adult patients with glioblastoma. Novocure
has ongoing or completed clinical trials investigating TTFields in brain
metastases, non-small cell lung cancer, pancreatic cancer, ovarian
cancer and mesothelioma.

Headquartered in Jersey, Novocure has U.S. operations in Portsmouth, New
Hampshire, Malvern, Pennsylvania and New York City. Additionally, the
company has offices in Germany, Switzerland, Japan and Israel. For
additional information about the company, please visit
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