2009-12-02 07:17:54 -
London, December , 02, 2009
Corporate news announcement processed and transmitted by Hugin AS.
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* Late-breaking abstract to report data from pivotal trial of
Tasigna® versus Glivec® in newly diagnosed patients with a form
of chronic myeloid leukemia
* Data from Phase II studies to show the potential of everolimus in
a rare form of non-Hodgkin lymphoma and of panobinostat in
Hodgkin lymphoma[1],[2]
* Oral presentation featuring early data on midostaurin to show
promise in FLT3-mutated acute myeloid leukemia[3]
* New data to be presented on a Janus kinase (JAK) inhibitor,
recently added to the Novartis Oncology pipeline[4],[5]
* Two-year data from EPIC trial to demonstrate Exjade® continues to
significantly reduce toxic iron that can damage the heart of
chronically transfused patients[6]
Basel, December 2, 2009 - Novartis announced today that new data,
including a late-breaking presentation on Tasigna® (nilotinib) in a
form of chronic myeloid leukemia, demonstrate the strength of the
company's hematology portfolio in advancing the care of patients.
The new data, at the 51st American Society of Hematology (ASH) Annual
Meeting and Exposition, highlight the company's current therapies and
investigational agents in 195 studies including 39 oral
presentations. Data will be presented on Tasigna, Afinitor®
(everolimus) tablets, Exjade® (deferasirox) and pipeline agents
including PKC412 (midostaurin), LBH589 (panobinostat), BHQ880 and
INCB18424, an oral, selective Janus kinase (JAK) inhibitor that was
recently added to the oncology pipeline through a licensing
agreement.
"Data presented at ASH will demonstrate the vigorous research
underway to explore the best treatment approaches for patients with
rare blood cancers and conditions," said David Epstein, President and
CEO, Novartis Oncology and Novartis Molecular Diagnostics. "We expect
these data to lay the groundwork for regulatory submissions and
provide a roadmap for the initiation of late-stage and pivotal
trials."
The ASH Annual Meeting will feature results from a pivotal
head-to-head study comparing the efficacy and safety of Tasigna
versus Glivec® (imatinib)* in adult patients with newly diagnosed
Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML)
in chronic phase (Abstract #LBA-1; Tuesday, December 8, 2009 at 7:30
AM CST).
Data from this Phase III clinical trial, ENESTnd (Evaluating
Nilotinib Efficacy and Safety in Clinical Trials of Newly Diagnosed
Ph+ CML Patients), will show that Tasigna produced faster and deeper
responses than Glivec when used as first-line therapy.
Other key presentations at ASH include:
* Everolimus Phase II data to show efficacy and safety in patients
with Waldenström's macroglobulinemia (WM) who had relapsed or
become resistant to prior treatment (Abstract #587; Monday,
December 7, 2009 at 3:45 PM CST)[1]
* LBH589 (panobinostat) data from two early phase studies to show
efficacy in heavily pre-treated patients with multiple myeloma
and Hodgkin lymphoma (Abstract #3852; Monday, December 7, 2009 at
6:00 PM CST; Abstract #923; Tuesday, December 8, 2009 at 8:30 AM
CST)[2],[7]
* PKC412 (midostaurin) early stage data will demonstrate benefit in
patients with FLT3-mutated acute myeloid leukemia when used in
combination with chemotherapy (Abstract #634; Monday, December 7,
2009 at 5:15 PM CST)[3]
* INCB18424 data from a Phase II study in advanced polycythemia
vera (PV) and essential thrombocythemia (ET) refractory to
hydroxyurea (Abstract #311; Monday, December 7, 2009, 8:00 AM
CST)[5]
* INCB18424 long-term follow-up data to demonstrate durable
clinical, functional and symptomatic responses with excellent
hematological safety in patients with myelofibrosis (Abstract
#756; Monday, December 7, 2009 at 5:45 PM CST)[4]
* Exjade two-year data from EPIC (Evaluation of Patients Iron
Chelation with Exjade) trial to show benefit of Exjade for
chronically transfused beta-thalassemia patients by continuing
to significantly reduce toxic iron that can damage the heart
(Abstract #4062; Monday, December 7, 2009 at 6:00 PM CST)[6]
* BHQ880 preliminary Phase I study data in combination with Zometa®
(zoledronic acid) and an approved anti-myeloma therapy in
patients with relapsed or refractory multiple myeloma who
experienced a prior skeletal-related event (Abstract #750;
Monday, December 7, 2009 at 5:45 PM CST)[8].[9]
The Novartis Oncology pipeline features compounds in all phases of
development, including six in late-stage development, and encompasses
a broad array of therapeutic strategies for fighting cancer.
About Tasigna[10]
Tasigna is approved in more than 80 countries for the treatment of
chronic phase and accelerated phase Ph+ CML in adult patients
resistant or intolerant to at least one prior therapy, including
Glivec. The effectiveness of Tasigna for this indication is based on
confirmed hematologic and unconfirmed cytogenetic response rates.
There are no controlled trials demonstrating a clinical benefit, such
as improvement in disease-related symptoms or increased survival.
Tasigna important safety information
Because taking Tasigna with food may increase the amount of drug in
the blood, Tasigna should not be taken with food and patients should
wait at least two hours after a meal before taking Tasigna. In
addition, no food should be consumed for at least one hour after the
dose is taken.
The most frequent Grade 3 or 4 adverse events for Tasigna were
primarily hematological in nature and included neutropenia and
thrombocytopenia. Elevations seen in bilirubin, liver function tests,
lipase enzymes and blood sugar, were mostly transient and resolved
over time. These cases were easily managed and rarely led to
discontinuation of treatment. Pancreatitis was reported in less than
1% of cases. The most frequent non-hematologic drug-related adverse
events were rash, pruritus, nausea, fatigue, headache, constipation
and diarrhea. Most of these adverse events were mild to moderate in
severity.
Tasigna should be used with caution in patients with uncontrolled or
significant cardiac disease (e.g., recent heart attack, congestive
heart failure, unstable angina or clinically significant
bradycardia), as well as in patients who have or may develop
prolongation of QTc. These include patients with abnormally low
potassium or magnesium levels, patients with congenital long QT
syndrome, patients taking anti-arrhythmic medicines or other drugs
that may lead to QT prolongation. Low levels of potassium or
magnesium must be corrected prior to Tasigna administration. Close
monitoring for an effect on the QTc interval is advisable and a
baseline echocardiogram is recommended prior to initiating therapy
with Tasigna and as clinically indicated.
About Glivec[11]
Glivec is approved in more than 90 countries, including the US, EU
and Japan, for the treatment of all phases of Ph+ CML. Glivec is also
approved in the US, EU and other countries for the treatment of
patients with Kit (CD117)-positive gastrointestinal tumors (GIST),
which cannot be surgically removed and/or have already spread to
other parts of the body (metastasized). In the US and EU, Glivec is
now approved for the post-surgery treatment of adult patients
following complete surgical removal of Kit (CD117)-positive
gastrointestinal stromal tumors. In the EU, Glivec is also approved
for the treatment of adult patients with newly diagnosed Ph+ acute
lymphoblastic leukemia (Ph+ ALL) in combination with chemotherapy and
as a single agent for patients with relapsed or refractory Ph+ ALL.
Glivec is also approved for the treatment of adult patients with
unresectable, recurrent and/or metastatic dermatofibrosarcoma
protuberans (DFSP) who are not eligible for surgery. Glivec is also
approved for the treatment of patients with
myelodysplastic/myeloproliferative diseases (MDS/MPD). Glivec is also
approved for hypereosinophilic syndrome and/or chronic eosinophilic
leukemia (HES/CEL).
The effectiveness of Glivec is based on overall hematological and
cytogenetic response rates and progression-free survival in CML, on
hematological and cytogenetic response rates in Ph+ ALL, MDS/MPD, on
hematological response rates in systemic mastocytosis (SM), HES/CEL,
on objective response rates and progression-free survival in
unresectable and/or metastatic GIST, on recurrence-free survival in
adjuvant GIST and on objective response rates in DFSP. Increased
survival in controlled trials has been demonstrated only in newly
diagnosed chronic phase CML and GIST.
Not all indications are available in every country.
Glivec important safety information
The majority of patients treated with Glivec in clinical trials
experienced adverse events at some time. Most events were of mild to
moderate grade and treatment discontinuation was not necessary in the
majority of cases.
The safety profile of Glivec was similar in all indications. The most
common side effects included nausea, superficial edema, muscle
cramps, skin rash, vomiting, diarrhea, abdominal pain, myalgia,
arthralgia, hemorrhage, fatigue, headache, joint pain, cough,
dizziness, dyspepsia and dyspnea, dermatitis, eczema and fluid
retention, as well as neutropenia, thrombocytopenia and anemia.
Glivec was generally well tolerated in all of the studies that were
performed, either as monotherapy or in combination with chemotherapy,
with the exception of a transient liver toxicity in the form of
transaminase elevation and hyperbilirubinemia observed when Glivec
was combined with high dose chemotherapy.
Rare/serious adverse reactions include: sepsis, pneumonia,
depression, convulsions, cardiac failure, thrombosis/embolism, ileus,
pancreatitis, hepatic failure, exfoliative dermatitis, angioedema,
Stevens-Johnson syndrome, renal failure, fluid retention, edema
(including brain, eye, pericardium, abdomen and lung), hemorrhage
(including brain, eye, kidney and gastrointestinal tract),
diverticulitis, gastrointestinal perforation, tumor
hemorrhage/necrosis and hip osteonecrosis/avascular necrosis.
Patients with cardiac disease or risk factors for cardiac failure
should be monitored carefully and any patient with signs or symptoms
consistent with cardiac failure should be evaluated and treated.
Cardiac screening should be considered in patients with HES/CEL, and
patients with MDS/MPD with high level of eosinophils (echocardiogram,
serum troponin level).
Glivec is contraindicated in patients with known hypersensitivity to
imatinib or any of its excipients. Women of childbearing potential
should be advised to avoid becoming pregnant while taking Glivec.
About everolimus
In the US, everolimus is approved under the trade name Afinitor for
the treatment of patients with advanced renal cell carcinoma (RCC)
after failure of treatment with sunitinib or sorafenib. In the
European Union (EU), Afinitor is approved for the treatment of
patients with advanced RCC whose disease has progressed on or after
treatment with vascular endothelial growth factor (VEGF)-targeted
therapy. Further, in the EU, everolimus is available in different
dosage strengths under the trade name Certican® for the prevention of
organ rejection in heart and kidney transplant recipients.
With once-daily dosing, everolimus continuously targets mammalian
target of rapamycin (mTOR) in cancer cells, a protein that acts as a
central regulator of tumor cell division, blood vessel growth and
cell metabolism. Everolimus is being studied in multiple tumor types,
including breast cancer, neuroendocrine tumors, gastric cancer,
hepatocellular carcinoma (HCC) and non-Hodgkin lymphoma (NHL), as
well as tuberous sclerosis complex (TSC).
As an investigational compound, the safety and efficacy profile of
everolimus has not yet been established in these cancer and tumor
types. Access to everolimus for these cancer and tumor types is
available through carefully controlled and monitored clinical trials.
These trials are designed to better understand the potential benefits
and risks of the compound. For more information about everolimus
clinical trials, healthcare professionals can visit
www.theWIDEprogram.com. Because of the uncertainty of clinical
trials, there is no guarantee that everolimus will ever become
commercially available for these cancer and tumor types anywhere in
the world.
Afinitor (everolimus) tablets important safety information
Afinitor is contraindicated in patients with hypersensitivity to
everolimus, to other rapamycin derivatives or to any of the
excipients.
Cases of non-infectious pneumonitis have been described; some of
these have been severe and occasionally fatal. Management of
pneumonitis may require dose adjustment and/or interruption, or
discontinuation of treatment and/or addition of corticosteroid
therapy.
Afinitor is immunosuppressive. Localized and systemic bacterial,
fungal, viral or protozoal infections (e.g., pneumonia,
aspergillosis, candidiasis, hepatitis B reactivation) have been
described; some of these have been severe and occasionally fatal.
Pre-existing infections should be treated prior to starting
treatment. Be vigilant for symptoms and signs of infection; in case
of emergent infections, institute appropriate treatment promptly and
consider interruption or discontinuation of Afinitor. Patients with
systemic invasive fungal infections should not receive Afinitor.
Mouth ulcers, stomatitis and oral mucositis have been seen in
patients treated with Afinitor. Monitoring of renal function, blood
glucose and complete blood counts is recommended prior to initiation
and periodically during treatment.
Afinitor is not recommended in patients with severe hepatic
impairment. Use of live vaccines should be avoided. Afinitor is not
recommended during pregnancy or for women of childbearing potential
not using contraception. Afinitor may cause fetal harm in pregnant
women. Women should not breast feed.
Avoid concurrent treatment with strong CYP3A4 and PgP inhibitors and
use caution with moderate inhibitors. Avoid concurrent treatment with
strong CYP3A4 or PgP inducers.
The most common adverse reactions (>=10%) include stomatitis, rash,
fatigue, asthenia, diarrhea, anorexia, nausea, mucosal inflammation,
vomiting, cough, infections, peripheral edema, dry skin, epistaxis,
pneumonitis, pruritus, dyspnea and dysgeusia. Common adverse
reactions (>=1 to <10%) include headache, dry mouth, pyrexia, weight
decreased, hand-foot syndrome, abdominal pain, erythema, insomnia,
dyspepsia, dysphagia, hypertension, increased daytime urination,
dehydration, chest pain, hemoptysis and exacerbation of diabetes
mellitus. Uncommon adverse reactions (<1%) include ageusia,
congestive cardiac failure, new-onset diabetes mellitus, impaired
wound healing, grade 1 hemorrhage and hepatitis B reactivation.
About Exjade
Exjade is approved in more than 90 countries, including the US,
Switzerland, Japan and the countries comprising the European Union.
Exjade is indicated for chronic iron overload due to blood
transfusions. The approved indication may vary depending upon the
individual country. Exjade is approved for use at doses up to 40
mg/kg in many countries, including the US, Canada, Australia, and
Switzerland. Exjade may be available in additional countries at
similar dosing pending approval. The European Medicines Agency (EMEA)
is currently considering an application for similar dosing (up to 40
mg/kg) in the European Union.
Disclaimer: The results seen in the EPIC study were achieved with a
starting dose of 30 mg/kg, which is not approved in all countries and
a dose range up to 45 mg/kg which is not approved in any country.
Exjade important safety information
Exjade is contraindicated in patients with hypersensitivity to the
active substance or to any of the excipients. Exjade has not been
studied in patients with renal impairment and is contraindicated in
patients with moderate/severe renal impairment.
Caution should be utilized in high-risk MDS patients and patients
with other hematological and non-hematological malignancies who are
not expected to benefit from chelation therapy due to the rapid
progression of their disease. Caution should be used in elderly
patients due to a higher frequency of adverse reactions.
There have been postmarketing reports of acute renal failure, hepatic
failure and cytopenias in patients treated with Exjade, some with a
fatal outcome. Monthly monitoring of serum creatinine, creatinine
clearance, proteinuria, serum transaminases is recommended, and the
dose of Exjade should be modified or interrupted if necessary. More
frequent creatinine monitoring is recommended in patients with an
increased risk of renal complications. Liver function tests should be
conducted every 2 weeks during the first month of treatment and
monthly thereafter. Upper gastrointestinal ulceration and hemorrhage
have been reported and caution should be exercised when combined with
drugs with ulcerogenic potential. There have been rare reports of
fatal GI hemorrhages, especially in elderly patients who had advanced
hematologic malignancies and/or low platelet counts. Caution should
be used in patients with platelet counts <50 x 1.000.000.000/L. Skin
rashes, including hypersensitivity reactions, have been reported.
Exjade should be interrupted if severe rash develops and discontinued
if severe hypersensitivity reaction occurs. Auditory and ophthalmic
testing should be conducted annually.
Exjade should not be taken with aluminium-containing antacids.
Caution should be exercised when Exjade is combined with drugs
metabolized through CYP3A4, CYP2C8 substrates, potent UGT inducers,
drugs with ulcerogenic potential and anticoagulants.
The most common adverse reactions in clinical trials are nausea,
vomiting, diarrhea, abdominal pain, rash, non-progressive increase in
serum creatinine, increased transaminases, abdominal distension,
constipation, dyspepsia, proteinuria and headache.
About midostaurin (PKC412)
Midostaurin is a multi-targeted kinase inhibitor that suppresses the
FLT3 receptor tyrosine kinase, resulting in increased cell death and
reduced cell division in tumors. The FLT3 gene is one of several
cancer genes associated with the development of AML and approximately
30% of AML patients will have a mutation in their FLT3 gene. Patients
who have this mutation have poor prognosis with reduced overall
survival, and show higher relapse rates when compared to patients who
do not have the mutation, often referred to as FLT3-wild-type.
There is an ongoing global randomized, placebo-controlled Phase III
clinical trial called CALGB 10603-RATIFY (Randomized AML Trial In
FLT3 in <60 Year Olds) to study midostaurin in combination with
standard chemotherapy in newly diagnosed patients with FLT3-mutated
AML. This is a multi-cooperative group global trial, sponsored by the
Cancer and Leukemia Group B (CALGB) in North America and Novartis
outside North America.
About panobinostat (LBH589)
Panobinostat is a potent pan-deacetylase (DAC) inhibitor. By
interfering in the nucleus with gene expression and transcription,
panobinostat decreases tumor cell division, causes tumor cell death
and inhibits the formation of new blood vessels that feed tumors.
Furthermore, in diseases that involve plasma cells such as multiple
myeloma, panobinostat inhibits HDAC6 (a key enzyme in the elimination
of pathologically hypersecreted monoclonal immunoglobulins) leading
to cell death.
About BHQ880
BHQ880 is a first-in-class, fully human, anti-dickkopf-1 (DKK-1)
neutralizing antibody. By inhibiting the DDK-1 antibody, BHQ880
promotes activity of osteoblasts, cells that form bones.
About INCB18424
INCB18424 (also known as INCB018424) is a Janus kinase (JAK)
inhibitor. This oral targeted therapy is now in Phase III clinical
trials for the treatment of myelofibrosis, a life-threatening
neoplastic condition with no effective medical treatment that is
characterized by varying degrees of bone marrow failure, splenomegaly
(enlarged spleen) and debilitating symptoms. INCB18424 has the
potential of becoming a first-in-class therapeutic agent for the
treatment of this and other hematologic diseases.
About Zometa
Zometa is indicated for the treatment or prevention of skeletal
related events (pathological fractures, spinal compression, radiation
or surgery to bone, or tumor-induced hypercalcemia) in patients with
advanced malignancies involving bone. An intravenous bisphosphonate,
Zometa is the only therapy to demonstrate efficacy in reducing or
delaying bone complications across a broad range of tumor types such
as breast, prostate, lung and renal cell cancers, in patients with
metastatic disease when administered monthly. Zometa offers patients,
nurses and clinicians a 4 mg, 15-minute infusion.
Zometa is the world's leading treatment for the prevention or delay
of skeletal-related events (SREs) in patients with advanced
malignancies involving bone across a broad range of tumors.
Laboratory research has suggested that Zometa may also help protect
patients from the spread of cancer to other parts of the body
(distant metastatic sites) and help keep patients recurrence-free.
Zometa important safety information
Zometa has been associated with reports of renal insufficiency.
Patients should be adequately rehydrated and have their serum
creatinine assessed prior to receiving each dose of Zometa. Due to
the risk of clinically significant deterioration in renal function,
single doses of Zometa should not exceed 4 mg and the duration of
infusion should be no less than 15 minutes in 100 ml of dilutent.
Severe and occasionally incapacitating bone, joint, and/or muscle
pain has been reported in patients taking bisphosphonates including
Zometa. Caution is advised when Zometa is used in aspirin-sensitive
patients, or with aminoglycosides, loop diuretics and other
potentially nephrotoxic drugs. Zometa contains the same active
ingredient (zoledronic acid) as found in Aclasta®. Patients being
treated with Zometa should not be treated with Aclasta concomitantly.
In clinical trials, the most commonly reported adverse events
included flu-like syndrome (fever, arthralgias, myalgias, skeletal
pain), fatigue, gastrointestinal reactions, anemia, weakness, cough,
dyspnea and edema. Zometa should not be used during pregnancy. Zometa
is contraindicated in patients with clinically significant
hypersensitivity to zoledronic acid or other bisphosphonates, or any
of the excipients in the formulation of Zometa.
Osteonecrosis of the Jaw (ONJ): ONJ has been reported in patients
with cancer receiving treatment including bisphosphonates,
chemotherapy, and/or corticosteroids. The majority of reported cases
have been associated with dental procedures such as tooth extraction.
A dental examination with appropriate preventive dentistry should be
considered prior to treatment with bisphosphonates in patients with
concomitant risk factors. While on treatment, these patients should
avoid invasive dental procedures if possible. No data are available
to suggest whether discontinuation of bisphosphonate therapy reduces
the risk of ONJ in patients requiring dental procedures. A causal
relationship between bisphosphonate use and ONJ has not been
established.
Not all indications are approved in every country. Please see full
Prescribing Information.
Disclaimer
The foregoing release contains forward-looking statements that can be
identified by terminology such as "potential," "to present," "to
show," "to demonstrate," "can," "will," "to explore," "pipeline," or
similar expressions, or by express or implied discussions regarding
potential new indications or labeling, or potential marketing
approvals for the products described in this release, or regarding
potential future revenues from such products. 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 to be materially different from any future
results, performance or achievements expressed or implied by such
statements. There can be no guarantee that any of the products or
additional indications or labeling described in this release will be
submitted for approval or approved for sale in any market. Nor can
there be any guarantee that any of these products will achieve any
particular levels of revenue in the future. In particular,
management's expectations regarding these products could be affected
by, among other things, 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; the company's ability to obtain or
maintain patent or other proprietary intellectual property
protection; competition in general; government, industry and general
public pricing pressures; 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 healthcare solutions that address the evolving
needs of patients and societies. Focused solely on healthcare,
Novartis offers a diversified portfolio to best meet these needs:
innovative medicines, cost-saving generic pharmaceuticals, preventive
vaccines, diagnostic tools and consumer health products. Novartis is
the only company with leading positions in these areas. In 2008, the
Group's continuing operations achieved net sales of USD 41.5 billion
and net income of USD 8.2 billion. Approximately USD 7.2 billion was
invested in R&D activities throughout the Group. Headquartered in
Basel, Switzerland, Novartis Group companies employ approximately
99,000 full-time-equivalent associates and operate in more than 140
countries around the world. For more information, please visit
www.novartis.com.
*Known as Gleevec® (imatinib mesylate) tablets in the US, Canada and
Israel.
References
[1] Ghobrial, et al. A Phase II Trial of the Oral mTOR Inhibitor
Everolimus (RAD001) in Relapsed or Refractory Waldenstrom's
Macroglobulinemia. 51st American Society of Hematology Annual Meeting
and Exposition, New Orleans, LA. December 5-8, 2009.
[2] Younes, et al. Efficacy of Panobinostat in Phase II Study in
Patients with Relapsed/Refractory Hodgkin Lymphoma (HL) After
High-Dose Chemotherapy with Autologous Stem Cell Transplant. 51st
American Society of Hematology Annual Meeting and Exposition, New
Orleans, LA. December 5-8, 2009.
[3] Stone, et al. A Phase 1b Study of Midostaurin (PKC412) in
Combination with Daunorubicin and Cytarabine Induction and High-Dose
Cytarabine Consolidation in Patients Under Age 61 with Newly
Diagnosed De Novo Acute Myeloid Leukemia: Overall Survival of
Patients Whose Blasts Have FLT3 Mutations is Similar to Those with
Wild-Type FLT3. 51st American Society of Hematology Annual Meeting
and Exposition, New Orleans, LA. December 5-8, 2009.
[4] Verstovsek, et al. Long-Term Follow Up and Optimized Dosing
Regimen of INCB018424 in Patients with Myelofibrosis: Durable
Clinical, Functional and Symptomatic Responses with Improved
Hematological Safety. 51st American Society of Hematology Annual
Meeting and Exposition, New Orleans, LA. December 5-8, 2009.
[5] Verstovsek, et al. A Phase 2 Study of INCB018424, An Oral,
Selective JAK1/JAK2 Inhibitor, in Patients with Advanced Polycythemia
Vera (PV) and Essential Thrombocythemia (ET) Refractory to
Hydroxyurea. 51st American Society of Hematology Annual Meeting and
Exposition, New Orleans, LA. December 5-8, 2009.
[6] Pennell, et al. Efficacy and Safety of Deferasirox (Exjade®) in ß
-Thalassemia Patients with Myocardial Siderosis: 2-Year Results From
the EPIC Cardiac Sub-Study. 51st American Society of Hematology
Annual Meeting and Exposition, New Orleans, LA. December 5-8, 2009.
[7] San-Miguel, et al. A Phase IB, Multi-Center, Open-Label
Dose-Escalation Study of Oral Panobinostat (LBH589) and I.V.
Bortezomib in Patients with Relapsed Multiple Myeloma. 51st American
Society of Hematology Annual Meeting and Exposition, New Orleans, LA.
December 5-8, 2009.
[8] Padmanabhan, et al. A Phase I/II Study of BHQ880, a Novel
Osteoblat Activating, Anti-DKK1 Human Monoclonal Antibody, in
Relapsed and Refractory Multiple Myeloma (MM) Patients Treated with
Zoledronic Acid (Zol) and Anti-Myeloma Therapy (MM Tx). 51st American
Society of Hematology Annual Meeting and Exposition, New Orleans, LA.
December 5-8, 2009.
[9] Zometa Prescribing Information. March 2008.
[10] Tasigna (nilotinib) European Summary of Characteristics.
Novartis AG.
www.tasigna.com/en/tasigna-product-information.jsp# .
[11] Glivec (imatinib) prescribing information. Basel, Switzerland:
Novartis International AG; March 2009.
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