Novartis drug Tasigna® receives FDA priority review for newly diagnosed patients with early-stage chronic myeloid leukemia
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Novartis International AG / Novartis drug Tasigna® receives FDA priority review for newly diagnosed patients with early-stage chronic myeloid leukemia processed and transmitted by Hugin AS. The issuer is solely responsible for the content of this announcement.
* Study results show Tasigna exceeds Glivec® in every measure of efficacy in
the trial including prevention of disease progression at 12 months[1]
* Regulatory applications underway worldwide for Tasigna in the first-line
indication with submissions now filed in the US, EU and Japan
* Tasigna, if approved, will be first treatment since Glivec for newly
diagnosed Philadelphia chromosome-positive chronic myeloid leukemia patients
in chronic phase
Basel,February 19, 2010 - Novartis announced today that Tasigna® (nilotinib) has
been granted priority review by the US Food and Drug Administration (FDA) for
the treatment of adult patients with newly diagnosed Philadelphia
chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase.
FDA priority review status is granted to therapies that offer major advances in
treatment or provide a treatment where no adequate therapy exists. This status
accelerates the standard review time from 10 to six months. Tasigna demonstrated
that significantly fewer patients progressed to more advanced stages of the
disease than the standard of care Glivec® (imatinib)* at 12 months. Tasigna also
showed a statistically significant improvement over Glivec in every other
measure of efficacy in the trial, including major molecular response (MMR) and
complete cytogenetic response (CCyR) at 12 months[1].
In addition to the US, regulatory submissions have been filed in the EU and
Japan. All filings are based on data showing superior efficacy for Tasigna in
the first head-to-head comparison of the drug against the standard of care
Glivec in newly diagnosed Ph+ CML patients.If approved for the first-line
indication, Tasigna will be the first drug for newly diagnosed patients to
become available since the approval of Glivec in 2002.
"Recently presented data showed that Tasigna surpassed Glivec in every measure
of treatment efficacy designated in the study including prevention of disease
progression at 12 months," said David Epstein, CEO of the Novartis
Pharmaceuticals Division. "Now this priority review designation brings us one
step closer to offering patients who are newly diagnosed with Ph+ CML in the
chronic phase a promising new treatment option."
The regulatory submissions are based on data from the ENESTnd (Evaluating
Nilotinib Efficacy and Safety in Clinical Trials of Newly Diagnosed Ph+ CML
Patients) Phase III clinical trial. This randomized, open-label, multicenter
trial compared the efficacy and safety of Tasigna versus Glivec in adult
patients with newly diagnosed Ph+ CML in chronic phase[1]. It is the largest
global randomized comparison of two oral therapies ever conducted in newly
diagnosed Ph+ CML patients.
In the ENESTnd clinical trial, significantly fewer patients at 12 months
progressed to accelerated or blastic phase on Tasigna 300 mg twice daily than on
Glivec 400 mg once daily (2 patients vs. 11 patients)[1], demonstrating a
significant improvement in disease control. Fewer patients discontinued due to
adverse events from the Tasigna 300 mg twice daily arm of the study compared to
the Glivec 400 mg once daily arm. No patients in the study had a prolongation
of the QT interval >500 milliseconds[1]. In addition, no sudden deaths occurred
with either treatment[2].
Tasigna is a potent and selective inhibitor of the Bcr-Abl protein that causes
production of cancer cells in Ph+ CML[2],[3]. The first clinical trials of
Tasigna began 21 months after its discovery, with the drug receiving its first
regulatory approval in the second-line indication in 2007[3].
About Ph+ CML
CML is a disease in which the body produces cancerous white blood cells. Almost
all patients with CML have an abnormality known as the Philadelphia chromosome,
which produces a protein called Bcr-Abl. Bcr-Abl causes malignant white blood
cells to proliferate[4]. Worldwide, CML is responsible for approximately 10 to
15% of all adult cases of leukemia[5], with an incidence of one to two cases per
100,000 people per year[6].
About Tasigna[3]
Tasigna has been 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 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[7]
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
insystemic 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.
Disclaimer
The foregoing release contains forward-looking statements that can be identified
by terminology such as "priority review," "will," "promising," or similar
expressions, or by express or implied discussions regarding potential approvals
of new indications or labeling for Tasigna, or the potential timing of such
approvals, or regarding potential future revenues from Tasigna or Glivec. 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 Tasigna or Glivec to be materially different from any future
results, performance or achievements expressed or implied by such statements.
There can be no guarantee that Tasigna will be approved for any additional
indications or labeling in any market, or at any particular time. Nor can there
be any guarantee that Tasigna or Glivec will achieve any particular levels of
revenue in the future. In particular, management's expectations regarding
Tasigna and Glivec could be affected by, among other things, unexpected
regulatory actions or delays or government regulation generally; unexpected
clinical trial results, including unexpected new clinical data and unexpected
additional analysis of existing clinical data; 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 2009, the Group's continuing operations achieved net sales of
USD 44.3 billion, while approximately USD 7.5 billion was invested in R&D
activities throughout the Group. Headquartered in Basel, Switzerland, Novartis
Group companies employ approximately 100,000 full-time-equivalent associates and
operate in more than 140 countries around the world. For more information,
please visithttp://www.novartis.com
*Known as Gleevec® (imatinib mesylate) tablets in the US, Canada and Israel
References
[1]Saglio G, Kim DW, Issaragrisil S, Philipp le Coutre, et al. Nilotinib
Demonstrates Superior Efficacy Compared with Imatinib in Patients with Newly
Diagnosed Chronic Myeloid Leukemia in Chronic Phase: Results from the
International Randomized Phase III ENESTnd Trial. Abstract #LBA-1. American
Society of Hematology 2009 Annual Meeting.
[2] Novartis data on file.
[3] Tasigna (nilotinib) European Summary of Characteristics.Novartis AG.
http://www.tasigna.com/en/tasi
n.jsp#
[4] National Cancer Institute. General Information About Chronic Myelogenous
Leukemia (PDQ).http://www.cancer.gov/cancertopics/pdq/treatment/CML/patient/.
Accessed March 2009.
[5] American Cancer Society. Detailed Guide: CML. What are the key statistics
about CML? (Sept 2008 revision). Available
at:http://www.cancer.org/docroot/CRI/content/CRI_2_4_1x_What_Are_the_Key_Statist
ics_About_Chronic_Myeloid_Leukemia_CML.asp?rnav=cri. Accessed April 2009.
[6] Central European Leukemia Study Group. About CML. Available
from:http://www.cml-info.com/de/healthcare-professionals/about-cml.html.
Accessed Nov 2009.
[7] Glivec® (imatinib) prescribing information. Basel, Switzerland: Novartis
International AG; March 2009.
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