Novartis compound LDK378 receives FDA Breakthrough Therapy designation for ALK+ non-small cell lung cancer
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Novartis compound LDK378 receives FDA Breakthrough Therapy designation for ALK+
non-small cell lung cancer
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* LDK378 is an investigational selective inhibitor of ALK[1], a target found
in a variety of cancers including metastatic non-small cell lung cancer
(NSCLC)
* Breakthrough Therapy designation is based on positive early data in patients
with ALK+ NSCLC who have been previously treated with crizotinib
* First filing for LDK378 anticipated in early 2014
Basel, March 15, 2013 - Novartis announced today that its investigational
compound LDK378 has received Breakthrough Therapy designation by the US Food and
Drug Administration (FDA) for the treatment of patients with anaplastic lymphoma
kinase positive (ALK+) metastatic non-small cell lung cancer (NSCLC) who had
progressed during treatment with, or were intolerant to, crizotinib. There are
limited treatment options for patients with ALK+ NSCLC, who tend to be non-
smokers and younger than NSCLC patients without an ALK translocation[2].
According to the FDA, Breakthrough Therapy designation is intended to expedite
the development and review of drugs that treat serious or life-threatening
conditions if the therapy has demonstrated substantial improvement over an
available therapy on at least one clinically significant endpoint. The
designation includes all of the fast track program features, as well as more
intensive FDA guidance. The Breakthrough Therapy designation is a distinct
status from both accelerated approval and priority review, which can also be
granted to the same drug if relevant criteria are met[3].
"LDK378 is a strong example of our research approach, which focuses on
identifying the underlying cause of disease pathways," said Alessandro Riva,
Global Head, Oncology Development & Medical Affairs, Novartis Oncology. "This
Breakthrough Therapy designation will allow us to collaborate more closely with
the FDA and potentially to expedite the availability of an important new
treatment option for patients with ALK+ NSCLC."
Initial results from a Phase I study investigating the maximum tolerated dose,
safety, pharmacokinetics and antitumor activity of LDK378 in 88 patients with
ALK+ advanced malignancies, as detected by an FDA-approved test and who had
progressed during treatment with, or were intolerant to, crizotinib, were
presented at the European Society of Medical Oncology 2012 annual congress. The
data showed marked responses in a majority of patients with ALK+ NSCLC[1]. A
response rate (including complete response [CR], partial response [PR] and
unconfirmed PR) of 80% was observed in the patients who had experienced disease
progression after crizotinib treatment[1].
Novartis has initiated two Phase II clinical trials to further evaluate the
compound in this patient population with plans to initiate several Phase III
clinical trials later this year. First regulatory filing is anticipated by early
2014.
About LDK378
LDK378 is a highly selective inhibitor of an important cancer target, anaplastic
lymphoma kinase (ALK)[1],[4]. Because it is an investigational compound, the
safety and efficacy profile of LDK378 has not yet been established. Access to
this investigational compound is available only through carefully controlled and
monitored clinical trials. These trials are designed to better understand the
potential benefits and risks of this compound. Because of the uncertainty of
clinical trials, there is no guarantee that LDK378 will ever be commercially
available anywhere in the world.
About NSCLC
Non-small cell lung cancer (NSCLC) is the most common type of lung cancer
accounting for 85-90% of all cases[5]. Approximately 3-8% of patients with NSCLC
have the ALK gene mutation[1]. There are limited treatment options for patients
with ALK+ NSCLC, who tend to be non-smokers and younger than NSCLC patients
without an ALK translocation.[2]
Disclaimer
The foregoing release contains forward-looking statements that can be identified
by terminology such as "can," "will," "potentially," "plans," "potential," or
similar expressions, or by express or implied discussions regarding potential
marketing approvals for LDK378 or regarding potential future revenues from
LDK378. You should not place undue reliance on these statements. Such forward-
looking statements reflect the current views of management regarding future
events, and involve known and unknown risks, uncertainties and other factors
that may cause actual results with LDK378 to be materially different from any
future results, performance or achievements expressed or implied by such
statements. There can be no guarantee that LDK378 will be submitted or approved
for sale in any market, or at any particular time. Nor can there be any
guarantee that LDK378 will achieve any particular levels of revenue in the
future. In particular, management's expectations regarding LDK378 could be
affected by, among other things, negative or otherwise unexpected clinical trial
results, including unexpected new clinical data and unexpected additional
analysis of existing clinical data; unexpected regulatory actions or delays or
government regulation generally; government, industry and general public pricing
pressures; competition in general; the company's ability to obtain or maintain
patent or other proprietary intellectual property protection; the impact that
the foregoing factors could have on the values attributed to the Novartis
Group's assets and liabilities as recorded in the Group's consolidated balance
sheet, and other risks and factors referred to in Novartis AG's current Form 20-
F on file with the US Securities and Exchange Commission. Should one or more of
these risks or uncertainties materialize, or should underlying assumptions prove
incorrect, actual results may vary materially from those anticipated, believed,
estimated or expected. Novartis is providing the information in this press
release as of this date and does not undertake any obligation to update any
forward-looking statements contained in this press release as a result of new
information, future events or otherwise.
About Novartis
Novartis provides innovative healthcare solutions that address the evolving
needs of patients and societies. Headquartered in Basel, Switzerland, Novartis
offers a diversified portfolio to best meet these needs: innovative medicines,
eye care, cost-saving generic pharmaceuticals, preventive vaccines and
diagnostic tools, over-the-counter and animal health products. Novartis is the
only global company with leading positions in these areas. In 2012, the Group
achieved net sales of USD 56.7 billion, while R&D throughout the Group amounted
to approximately USD 9.3 billion (USD 9.1 billion excluding impairment and
amortization charges). Novartis Group companies employ approximately 128,000
full-time-equivalent associates and operate in more than 140 countries around
the world. For more information, please visit http://www.novartis.com.
Novartis is on Twitter. Sign up to follow (at)Novartis at
http://twitter.com/novartis.
References
[1] Shaw A, et al. Results of a First-in-Human Phase I Study of the ALK Inhibitor LDK378 in
Advanced Malignancies. Abstract #4400. 2012 European Society for Medical Oncology (ESMO)
Annual Meeting, Vienna, Austria.
[2] Shaw A, et al. Targeting Anaplastic Lymphoma Kinase in Lung Cancer. Clin Cancer Res
2011;17:2081-2086.
[3] U.S. Food and Drug Administration. Frequently Asked Questions: Breakthrough Therapies.
Available at:
http://www.fda.gov/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/
SignificantAmendmentstotheFDCAct/FDASIA/ucm341027.htm. Accessed Mar 12, 2013.
[4] Mehra R et al. First-in-Human Phase I Study of the ALK Inhibitor LDK378 in Advanced Solid
Tumors. Abstract #3007. American Society of Clinical Oncology 2012 Annual Meeting,
Chicago, IL.
[5] American Cancer Society. Lung Cancer - Non-Small Cell Detailed Guide. Available at:
http://www.cancer.org/Cancer/LungCancer-Non-SmallCell/DetailedGuide/non-small-cell-lung-
cancer-what-is-non-small-cell-lung-cancer. Accessed Mar 12, 2013.
# # #
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Datum: 15.03.2013 - 07:16 Uhr
Sprache: Deutsch
News-ID 239736
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contact information:
Town:
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Business News
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