Novocure Announces FDA Acceptance of the PMA Application for TTFields Therapy in Non-Small Cell Lung Cancer
January 18 2024 - 7:00AM
Business Wire
Novocure (NASDAQ: NVCR) today announced that its Premarket
Approval (PMA) application seeking approval for the use of Tumor
Treating Fields (TTFields) therapy together with standard systemic
therapies for the treatment of non-small cell lung cancer (NSCLC),
following progression on or after platinum-based therapy, has been
accepted for filing by the U.S. Food and Drug Administration
(FDA).
“We are thrilled to announce the FDA has accepted our PMA
application for review of the LUNAR data in NSCLC,” said Asaf
Danziger, Novocure’s Chief Executive Officer. “This significant
milestone brings us one step closer to treating patients seeking
treatment for NSCLC, post-platinum, for which very few effective
non-toxic options exist today. I would like to thank our
investigators and patients, as well as our Novocure colleagues, for
their dedication in pursuit of bringing our novel therapy to
thousands of patients in need.”
The PMA application for LUNAR was submitted with a filing date
of December 15, 2023, and is now under substantive review by the
FDA. Novocure expects to receive a regulatory decision from FDA in
second half 2024.
About LUNAR
LUNAR tested the safety and effectiveness of TTFields therapy
when used together with either an immune checkpoint inhibitor (ICI)
or docetaxel for the treatment of patients diagnosed with
metastatic NSCLC following progression on or after the use of
platinum-based therapy. Patients randomized to receive TTFields
therapy together with standard therapies (n=137) demonstrated
median overall survival (OS) of 13.2 months compared to 9.9 months
in patients treated with standard therapies alone (n=139). Patients
randomized to receive TTFields therapy and physician’s choice ICI
(n=66) demonstrated a median OS of 18.5 months versus a median OS
of 10.8 months in patients treated with an ICI alone (n=68;
HR=0.63; P=0.03). Patients randomized to receive TTFields therapy
and docetaxel (n=71) had a positive survival trend with a median OS
of 11.1 months vs 8.7 months in patients treated with docetaxel
alone (n=71). TTFields therapy was well-tolerated with no added
systemic toxicities and few grade 3 (no grade 4 or 5)
device-related adverse events.
About NSCLC
Lung cancer is the most common cause of cancer-related death
worldwide, and NSCLC accounts for approximately 85% of all lung
cancers. It is estimated that approximately 193,000 patients are
diagnosed with NSCLC each year in the U.S. Physicians use different
combinations of surgery, radiation and pharmacological therapies to
treat NSCLC, depending on the stage of the disease. Surgery, which
may be curative in a subset of patients, is usually used in early
stages of the disease. Since 1991, radiation with a combination of
platinum-based chemotherapy drugs has been the first-line standard
of care for locally advanced or metastatic NSCLC. Certain immune
checkpoint inhibitors have been approved for the first-line
treatment of NSCLC and the standard of care in this setting appears
to be evolving rapidly. The standard of care for second-line
treatment is also evolving and may include platinum-based
chemotherapy for patients who received immune checkpoint inhibitors
as their first-line regimen, docetaxel, immune checkpoint
inhibitors or pemetrexed.
About Novocure
Novocure is a global oncology company working to extend survival
in some of the most aggressive forms of cancer through the
development and commercialization of its innovative therapy, Tumor
Treating Fields. Novocure’s commercialized products are approved in
certain countries for the treatment of adult patients with
glioblastoma, malignant pleural mesothelioma and pleural
mesothelioma. Novocure has ongoing or completed clinical trials
investigating Tumor Treating Fields in brain metastases, gastric
cancer, glioblastoma, liver cancer, non-small cell lung cancer,
pancreatic cancer and ovarian cancer.
Headquartered in Root, Switzerland and with a growing global
footprint, Novocure has regional operating centers in Portsmouth,
New Hampshire and Tokyo, as well as a research center in Haifa,
Israel. For additional information about the company, please visit
Novocure.com and follow @Novocure on LinkedIn and Twitter.
Forward-Looking Statements
In addition to historical facts or statements of current
condition, this press release may contain forward-looking
statements. Forward-looking statements provide Novocure’s current
expectations or forecasts of future events. These may include
statements regarding anticipated scientific progress on its
research programs, clinical study progress, development of
potential products, interpretation of clinical results, prospects
for regulatory approval, manufacturing development and
capabilities, market prospects for its products, coverage,
collections from third-party payers and other statements regarding
matters that are not historical facts. You may identify some of
these forward-looking statements by the use of words in the
statements such as “anticipate,” “estimate,” “expect,” “project,”
“intend,” “plan,” “believe” or other words and terms of similar
meaning. Novocure’s performance and financial results could differ
materially from those reflected in these forward-looking statements
due to general financial, economic, environmental, regulatory and
political conditions as well as issues arising from the COVID-19
pandemic and other more specific risks and uncertainties facing
Novocure such as those set forth in its Annual Report on Form 10-K
filed on February 23, 2023, and subsequent filings with the U.S.
Securities and Exchange Commission. Given these risks and
uncertainties, any or all of these forward-looking statements may
prove to be incorrect. Therefore, you should not rely on any such
factors or forward-looking statements. Furthermore, Novocure does
not intend to update publicly any forward-looking statement, except
as required by law. Any forward-looking statements herein speak
only as of the date hereof. The Private Securities Litigation
Reform Act of 1995 permits this discussion.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20240118299860/en/
Investors & Media: Ingrid Goldberg 610-723-7427
investorinfo@novocure.com media@novocure.com
NovoCure (NASDAQ:NVCR)
Historical Stock Chart
From Mar 2024 to Apr 2024
NovoCure (NASDAQ:NVCR)
Historical Stock Chart
From Apr 2023 to Apr 2024