Novartis announces outcome of FDA advisory committee meeting for multiple myeloma investigational compound LBH589
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Novartis International AG /
Novartis announces outcome of FDA advisory committee meeting for multiple
myeloma investigational compound LBH589
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* Committee votes against recommending LBH589 plus bortezomib and
dexamethasone for patients with previously treated multiple myeloma
* LBH589 has the potential to be an important treatment option for multiple
myeloma patients and Novartis will continue working with the FDA on a path
forward
Basel, November 6, 2014 - Novartis announced today that the US Food and Drug
Administration's (FDA) Oncologic Drugs Advisory Committee (ODAC) did not
recommend the investigational compound LBH589 (panobinostat), a pan-deacetylase
(pan-DAC) inhibitor, for patients with previously treated multiple myeloma when
used in combination with bortezomib[*] and dexamethasone.
The Committee's vote will be considered by the FDA in its review of the LBH589
new drug application (NDA), but the FDA is not bound to follow the Committee's
guidance. The final decision regarding US approval is made by the FDA.
"We are disappointed by this voting outcome and believe the results from our
clinical trials provide strong evidence to support LBH589 as a potential first-
in-class treatment option for multiple myeloma, a cancer where an unmet patient
need exists," said Bruno Strigini, President, Novartis Oncology. "We will
continue to work with the FDA as it completes its review of the US application."
Data presented at today's meeting included two clinical studies evaluating
LBH589 in combination with bortezomib and dexamethasone for patients with
relapsed or relapsed and refractory multiple myeloma: a Phase III randomized,
double-blind, placebo-controlled, multicenter global registration trial called
PANORAMA-1 (PANobinostat ORAl in Multiple MyelomA) and a Phase II US
multicenter, single-arm, open-label study called PANORAMA-2[1].
About multiple myeloma and LBH589
Multiple myeloma is a cancer of the plasma cells, a kind of white blood cell
present in bone marrow-the soft, blood-producing tissue that fills the center of
most bones. The cancer is caused by the production and growth of abnormal cells
within the plasma, which multiply and build up in the bone marrow, pushing out
healthy cells and preventing them from functioning normally[2]. Multiple myeloma
is an incurable disease with a high rate of relapse (when the cancer returns)
and patients often become refractory (unresponsive to therapy), despite
currently available treatments[3]. It typically occurs in individuals 60 years
of age or older, with few cases in individuals younger than 40[4].
Epigenetics is the cell programming that governs gene expression and cell
development[5]. In multiple myeloma, the normal epigenetic process is disrupted
(also called epigenetic dysregulation) resulting in the growth of cancerous
plasma cells, potential resistance to current treatment and ultimately disease
progression[6],[7].
LBH589 is a potent pan-deacetylase (pan-DAC) inhibitor that if approved will be
a first-in-class therapy for patients with previously treated multiple
myeloma[8]. As an epigenetic regulator, LBH589 may help restore cell programming
in multiple myeloma[9].
Because LBH589 is an investigational compound, the safety and efficacy profile
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 the
compound. Because of the uncertainty of clinical trials, there is no guarantee
that LBH589 will ever be commercially available anywhere in the world.
Disclaimer
The foregoing release contains forward-looking statements that can be identified
by words such as "votes against recommending," "potential," "will," "did not
recommend," "investigational," "may," "yet," or similar terms, or by express or
implied discussions regarding potential marketing approvals for LBH589, or
regarding potential future revenues from LBH589. You should not place undue
reliance on these statements. Such forward-looking statements are based on the
current beliefs and expectations of management regarding future events, and are
subject to significant known and unknown risks and uncertainties. Should one or
more of these risks or uncertainties materialize, or should underlying
assumptions prove incorrect, actual results may vary materially from those set
forth in the forward-looking statements. There can be no guarantee that LBH589
will be approved for sale in any market where it has been submitted, or at any
particular time. Neither can there be any guarantee that LBH589 will be
submitted or approved for sale in any additional markets, or at any particular
time. Nor can there be any guarantee that LBH589 will be commercially successful
in the future. In particular, management's expectations regarding LBH589 could
be affected by, among other things, the uncertainties inherent in research and
development, including unexpected clinical trial results and additional analysis
of existing clinical data; unexpected regulatory actions or delays or government
regulation generally; the company's ability to obtain or maintain proprietary
intellectual property protection; general economic and industry conditions;
global trends toward health care cost containment, including ongoing pricing
pressures; unexpected manufacturing issues, and other risks and factors referred
to in Novartis AG's current Form 20-F on file with the US Securities and
Exchange Commission. 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, over-the-
counter and animal health products. Novartis is the only global company with
leading positions in these areas. In 2013, the Group achieved net sales of USD
57.9 billion, while R&D throughout the Group amounted to approximately USD 9.9
billion (USD 9.6 billion excluding impairment and amortization charges).
Novartis Group companies employ approximately 133,000 full-time-equivalent
associates and sell products in more than 150 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] Novartis LBH589 ODAC Briefing Book.
[2] American Cancer Society. Multiple Myeloma. Available at:
http://www.cancer.org/acs/groups/cid/documents/webcontent/003121-pdf.pdf.
Accessed July 2014.
[3] The Leukemia and Lymphoma Society. Myeloma. Revised 2013;1:48.
[4] National Cancer Institute. SEER Stat Fact Sheets: Myeloma. Available at:
http://seer.cancer.gov/statfacts/html/mulmy.html. Accessed July 2014.
[5] Grønbæk K, Treppendahl M, Asmarand F, Guldberg P. Epigenetic Changes in
Cancer as Potential Targets for Prophylaxis and Maintenance Therapy. Basic &
Clinical Pharmacology & Toxicology. 2008;103:389-396
[6] Smith EM, Boyd K, Davies FE. The Potential Role of Epigenetic Therapy in
Multiple Myeloma. Br J Haematol. 2009;148:702-713.
[7] Muntean AG, Hess JL. Epigenetic Dysregulation in Cancer. Am J Pathol.
2009;175:1353-1361.
[8] San-Miguel J, et al. Randomized Phase III Trial of Panobinostat Plus
Bortezomib and Dexamethasone Versus Placebo Plus Bortezomib and Dexamethasone in
Relapsed or Relapsed and Refractory Multiple Myeloma. The Lancet Oncology. 2014.
[9] Maes K, et al. Epigenetic Modulating Agents as a New Therapeutic Approach in
Multiple Myeloma. Cancers. 2013;5:430-461
# # #
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--------------------------------------------------------------------------------
[*]Trade name Velcade(® )registered to Millennium Pharmaceuticals, Inc.
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Datum: 06.11.2014 - 18:41 Uhr
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