Basel, November 16, 2016 - Novartis will present data demonstrating the latest advancements from its oncology research program at the 58 th American Society of Hematology (ASH) Annual Meeting & Exposition, San Diego, December 3-6, and the San Antonio Breast Cancer Symposium (SABCS), San Antonio, December 6-10. Presentations will focus on a number of cancers, including leukemia, lymphoma, myelofibrosis and breast cancer, as well as chronic iron overload. The data reinforce Novartis' dedication to developing transformative therapies and treatment strategies to improve and extend the lives of people living with these diseases.
"Novartis continues to invest in not only creating new medicines for underserved patient communities, but also in redefining cancer treatment goals," said Bruno Strigini, CEO, Novartis Oncology. "Our ASH and SABCS data, including personalized cell and targeted therapies of the future, underscore our core belief in treating each patient as an individual, not just the disease."
Most notable among Novartis' clinical data to be featured at the two meetings are from the ongoing registrational trials for investigational CTL019* and LEE011** (ribociclib). The CTL019 data will be included in upcoming regulatory submissions. Novartis also recently received US Food and Drug Administration Priority Review for LEE011 (ribociclib) plus letrozole as first-line treatment for postmenopausal women with HR+/HER2- advanced or metastatic breast cancer, based on results from the MONALEESA-2 study.
Novartis will also be presenting safety, efficacy and quality of life data at ASH from its hematology portfolio, including an investigational use for Tasigna ® (nilotinib). Five-year pooled overall survival data for Jakavi ® (ruxolitinib)*** in patients with myelofibrosis and patient-reported health-related outcomes from patients with chronic immune thrombocytopenia taking Revolade ® (eltrombopag)**** will also be presented.
Sandoz, a Novartis division, the pioneer and global leader in biosimilars, will present pivotal Phase III safety and efficacy data for its proposed biosimilar rituximab.
Additional abstracts of note from each meeting are as follows.
ASH: Data for investigational therapies
ASH: Data for approved therapies
Exjade ® /Jadenu(TM) (deferasirox)
Jakavi ® (ruxolitinib)
ASH: Investigational use of approved therapies
Revolade ® /Promacta ® (eltrombopag)
Tasigna ® (nilotinib)
SABCS: Data for investigational therapies
SABCS: Investigational use of approved therapies
Afinitor ® (everolimus)
Novartis Oncology will host dedicated content on the company website ( http://www.novartisoncology.com ) throughout ASH and SABCS, featuring unique insights and perspectives on emerging areas of cancer care and research. Additionally, follow @NovartisCancer on Twitter for the latest oncology news and insights on cancer research.
Approved indications for products vary by country and not all indications are available in every country. The product safety and efficacy profiles have not yet been established outside the approved indications. Because of the uncertainty of clinical trials, there is no guarantee that the compounds will become commercially available with additional indications.
For full prescribing information, including approved indications and important safety information about globally marketed products, please visit
Because CTL019, LEE011 (ribociclib), ABL001, PKC412 (midostaurin) and BKM120 (buparlisib) are investigational compounds, the safety and efficacy profiles have not yet been fully established. Access to these investigational compounds is available only through carefully controlled and monitored clinical trials. These trials are designed to better understand the potential benefits and risks of the compounds. Because of the uncertainty of clinical trials, there is no guarantee that CTL019, LEE011 (ribociclib), ABL001, PKC412 (midostaurin) and BKM120 (buparlisib) will ever become commercially available anywhere in the world.
The foregoing release contains forward-looking statements that can be identified by words such as "will," "dedication," "continues to invest," "therapies of the future," "to be featured," "ongoing," "investigational," "upcoming," "emerging," or similar terms, or by express or implied discussions regarding potential new indications or labeling for Tasigna, Jakavi, Promacta, Revolade, Exjade, Jadenu and Afinitor, potential marketing approvals for CTL019, LEE011, ABL001, PKC412 and BKM120, or regarding potential future revenues from such products and investigational compounds. 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 Tasigna, Jakavi, Promacta, Revolade, Exjade, Jadenu or Afinitor will be submitted or approved for any additional indications or labeling in any market, or at any particular time. Neither can there be any guarantee that CTL019, LEE011, ABL001, PKC412 or BKM120 will be approved for sale in any market, or at any particular time. Nor can there be any guarantee that such products and investigational compounds will be commercially successful in the future. In particular, management's expectations regarding these products and investigational compounds 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 safety, quality or 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 and cost-saving generic pharmaceuticals. Novartis is the only global company with leading positions in these areas. In 2015, the Group achieved net sales of USD 49.4 billion, while R&D throughout the Group amounted to approximately USD 8.9 billion (USD 8.7 billion excluding impairment and amortization charges). Novartis Group companies employ approximately 118,000 full-time-equivalent associates. Novartis products are available approximately 180 countries around the world. For more information, please visit http://www.novartis.com .
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* Novartis and the University of Pennsylvania's Perelman School of Medicine (Penn) have a global collaboration to research, developand commercialize chimeric antigen receptor (CAR) T cell therapies for the investigational treatment of cancers.
** LEE011 was developed by the Novartis Institutes for BioMedical Research (NIBR) under a research collaboration with Astex Pharmaceuticals.
*** Jakavi is a registered trademark of Novartis AG in countries outside the United States. Jakafi is a registered trademark of Incyte Corporation. Novartis licensed ruxolitinib from Incyte Corporation for development and commercialization outside the United States.
**** Marketed as Promacta ® in the US.
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Last updated on: 17/11/2016
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