Basel, November 25, 2014 - Novartis announced today that the US Food and Drug Administration (FDA) has extended their priority review period by up to three months for the new drug application (NDA) of LBH589 (panobinostat) in combination with bortezomib* and dexamethasone for patients with previously treated multiple myeloma.
The NDA for LBH589 was submitted to the FDA in March 2014. In May 2014, the FDA granted priority review status to LBH589, reducing the standard 12-month review period to eight months. The extension to the LBH589 NDA review period follows an FDA Oncologic Drugs Advisory Committee (ODAC) meeting earlier this month.
"We are committed to working with the FDA as they continue to review the LBH589 NDA," said Alessandro Riva, MD, Global Head of Oncology Development and Medical Affairs, Novartis Oncology. "Multiple myeloma remains an incurable cancer where patients who have relapsed or become resistant to available therapies need new treatment options."
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. 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. It typically occurs in individuals 60 years of age or older, with few cases in individuals younger than 40.
Epigenetics is the cell programming that governs gene expression and cell development. 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,.
LBH589 is a potent pan-deacetylase (pan-DAC) inhibitor that if approved could be a first-in-class treatment for patients with relapsed or relapsed and refractory multiple myeloma. As an epigenetic regulator, LBH589 may help restore cell programming in multiple myeloma.
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.
* Trade name Velcade® registered to Millennium Pharmaceuticals, Inc.
The foregoing release contains forward-looking statements that can be identified by words such as "investigational," "committed," "continues," "could," "may," "yet," "will," 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.
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.
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 American Cancer Society. Multiple Myeloma. Available at: http://www.cancer.org/acs/groups/cid/documents/webcontent/003121-pdf.pdf. Accessed November 2014
 The Leukemia and Lymphoma Society. Myeloma. Revised 2013;1:48.
 National Cancer Institute. SEER Stat Fact Sheets: Myeloma. Available at: http://seer.cancer.gov/statfacts/html/mulmy.html. Accessed November 2014.
 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.
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 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.
 Maes K, et al. Epigenetic Modulating Agents as a New Therapeutic Approach in Multiple Myeloma. Cancers. 2013;5:430-461.
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