A Worldwide Support Network For Chronic Myelogenous Leukemia
Posted by rob on June 7, 2006 under Uncategorized | 
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To get information about 500 public and private patient assistance programs which provide more than 2,500 medicines, visit www.pparx.org or call 888-4PPA-NOW (888-477-2669).
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Although patients seldom know it, many patient groups and drug companies maintain close, multimillion-dollar relationships while disclosing limited or no details about the ties
Posted by rob on June 5, 2006 under Uncategorized | Read the First Comment
Using combinations of “smart bomb” cancer drugs that target specific proteins and avoid the indiscriminate cell destruction of chemotherapy may be the wave of the future for cancer patients, experts say.
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Big Pharma has discovered cancer.
For several years biotechnology companies like Genentech and ImClone have garnered most of the attention at the nation’s largest cancer meeting with new so-called targeted drugs that were in general less toxic than traditional chemotherapy.
But this year, the most significant data on targeted drugs is coming from the traditional big pharmaceutical companies.
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* New worldwide program addresses unmet medical need for patients with treatment-resistant Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML)
EAST HANOVER, N.J., June 04, 2006 /PRNewswire/ — Novartis announced today the launch of a global program, ENACT (Expanding Nilotinib Access in Clinical Trials), to provide expanded access to nilotinib (AMN107), a compound currently in late-stage registration trials for treating certain forms of the life-threatening disease leukemia.
This program is available to eligible patients in all phases of Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) who are either resistant to or intolerant of treatment with Gleevec(R) (imatinib mesylate)* tablets. Novartis is now planning to submit nilotinib for US and EU regulatory approval in late 2006 compared to earlier estimates for submissions in 2007.
“ENACT is another example of our ongoing commitment to making innovative therapies available to patients who need new treatment options,” said David Epstein, President of Novartis Oncology. “With Gleevec, Novartis launched a wide-ranging access program that enabled more than 9,000 patients around the world to obtain Gleevec at no cost before it became commercially available. This program continues our dedication to patients by providing an option to those who are no longer responding to Gleevec.”
Information about ENACT can be found on the clinical trial website of the US National Institutes of Health, www.clinicaltrials.gov. Information is also available by calling 1-800-340-6843 or by visiting www.novartisclinicaltrials.com. Physicians can access information at www.amn107.com.
About nilotinib
Nilotinib represents the next generation targeted, oral therapy specifically designed to be the most selective inhibitor of Bcr-Abl, the definitive cause of Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML), and its mutations. Designed in the biomedical research facilities of Novartis, nilotinib is a tyrosine kinase inhibitor with high affinity and specificity to attach itself to Bcr-Abl, the definitive cause of Ph+ CML, and 32 of 33 mutant forms most commonly associated with the disease.
The US Food and Drug Administration (FDA) has granted both fast track designation and orphan drug status to nilotinib. Nilotinib also received orphan drug status from the European Medicines Evaluation Agency (EMEA).
As an investigational compound, the safety and efficacy profile of nilotinib has not yet been established. Data from a Phase I clinical trial presented at the 2005 Annual Meeting of the American Society of Hematology (ASH) showed complete hematologic responses in 92% of patients in chronic phase, as well as hematologic responses in 76% of patients in accelerated phase and in 42% of patients in myeloid blast crisis. Cytogenetic responses were also seen in 53% of patients in chronic phase, 55% in accelerated phase and 29% in myeloid blast crisis.
Access to nilotinib is available only through carefully controlled and monitored clinical trials. These trials are designed to better understand the compound’s potential benefits and risks and data will be filed with regulatory authorities such as the FDA and the EMEA for regulatory approval.
About Gleevec
Gleevec (imatinib mesylate) tablets are indicated for the treatment of newly diagnosed adult patients with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase. Follow-up is limited. Gleevec tablets are also indicated for the treatment of patients with Ph+ CML in blast crisis, in accelerated phase, or in chronic phase after failure of interferon- alpha (IFN-a) therapy.
Important Safety Information(1)
Severe (NCI Grades 3/4) lab abnormalities-including neutropenia (3%-48%), anemia (<1%-42%), thrombocytopenia (<1%-33%), and hepatotoxicity (3%-6%)-and severe adverse experiences (NCI Grades 3/4), including severe fluid retention (eg, pleural effusion, pulmonary edema, and ascites) and superficial edema (1.8%-11%), hemorrhage (1%-19%) and musculoskeletal pain (2%-9%), were reported among Gleevec patients. Severe fluid retention appears to be dose related, was more common in the advanced phase studies (where the dosage was 600mg/day), and is more common in the elderly. Patients should be weighed and monitored regularly for signs and symptoms of edema, which can be serious or life-threatening. There have also been reports, including fatalities, of cardiac tamponade, cerebral edema, increased intracranial pressure, and papilledema and gastrointestinal perforation.
Bullous dermatologic reactions (eg, erythema multiforme and Stevens- Johnson syndrome) have also been reported. In some cases, the reaction recurred upon rechallenge. Several postmarketing cases note a resolution or improvement of bullous reaction following dose reduction with or without supportive care.
Dose adjustments may be necessary due to hepatotoxicity, other nonhematologic adverse events, or hematologic adverse events. Therapy with Gleevec was discontinued for adverse events in 3% to 5% of patients.
Patients with severe hepatic impairment should be treated at a starting dose of 300 mg/day and should be closely monitored.
Gleevec is metabolized by the CYP3A4 isoenzyme and is an inhibitor of CYP3A4, CYP2D6, and CYP2C9. Dosage of Gleevec tablets should increase by at least 50% and clinical response should be carefully monitored in patients receiving Gleevec tablets with a potent CYP3A4 inducer such as rifampin or phenytoin. Examples of commonly used drugs that may significantly interact with Gleevec include acetaminophen, warfarin, erythromycin, and phenytoin. (Please see full prescribing information for other potential drug interactions).
For daily dosing of 800mg and above, dosing should be accomplished using the 400mg tablets to reduce exposure to iron.
Use of Gleevec tablets is contraindicated in patients with hypersensitivity to imatinib or to any other component of Gleevec tablets.
Women of childbearing potential should be advised to avoid becoming pregnant while taking Gleevec tablets.
Because of the potential for serious adverse reactions in nursing infants, women should be advised to avoid breast-feeding while taking Gleevec tablets.
Common Side Effects(1)
The majority adult patients who received Gleevec in clinical studies experienced adverse events at some time. Most adverse events were mild to moderate in severity. The most frequently reported adverse events (all Grades) were superficial edema (58%-74%), nausea (47%-73%), muscle cramps (28%-62%), vomiting (21%-58%), diarrhea (39%-57%), musculoskeletal pain (38%-49%), and rash with related terms (26%-47%).**
Supportive care may help the management of most mild to moderate adverse events so that the prescribed dose can be maintained whenever possible.
Gleevec tablets should be taken with food and a large glass of water to minimize gastrointestinal (GI) irritation. Gleevec tablets should not be taken with grapefruit juice.
The foregoing release contains forward-looking statements that can be identified by terminology such as “planned,” “planning,” “will,” or similar expressions, or by express or implied discussions regarding potential new indications for nilotinib or potential future sales of nilotinib, or regarding the long-term impact of a patient’s use of nilotinib. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results with nilotinib to be materially different from any future results, performance or achievements expressed or implied by such statements. There can be no guarantee that nilotinib will be approved for any additional indications in any market. Nor can there be any guarantee regarding potential future sales of nilotinib. Neither can there be any guarantee regarding the long-term impact of a patient’s use of nilotinib. In particular, management’s expectations regarding commercialization of nilotinib could be affected by, among other things, additional analysis of nilotinib clinical data; new clinical data; unexpected clinical trial results; 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; and other risks and factors referred to in the Company’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 this information as of this date and does not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise.
About Novartis
Novartis Pharmaceuticals Corporation researches, develops, manufactures and markets leading innovative prescription drugs used to treat a number of diseases and conditions, including central nervous system disorders, organ transplantation, cardiovascular diseases, dermatological diseases, respiratory disorders, cancer and arthritis. The company’s mission is to improve people’s lives by pioneering novel healthcare solutions.
Located in East Hanover, New Jersey, Novartis Pharmaceuticals Corporation is an affiliate of Novartis AG — a world leader in pharmaceuticals and consumer health. In 2005, the Group’s businesses achieved sales of USD 32.2 billion and pro forma net income of USD 6.1 billion. The Group invested approximately USD 4.8 billion in R&D. Headquartered in Basel, Switzerland, Novartis Group companies employ approximately 91,000 people and operate in over 140 countries around the world. For further information please consult http://www.novartis.com.
* Known as Glivec(R) (imatinib) outside the US
** Numbers indicate the range of percentages in 4 studies among adult
patients with Ph+ CML in blast crisis, accelerated phase, and chronic
phase.
1. Gleevec(R) (imatinib mesylate) tablets prescribing information. East
Hanover, NJ: Novartis Pharmaceuticals Corporation; 2005.
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Geoff Cook Jill Pozarek
Novartis Oncology Novartis Corporation
P: 1 862-778-2675 P: 1 212-830-2445
F: 1 773-781-2074
Dana Kahn Cooper
P: 1 732-817-1800
F: 1 732-817-1834
Veronique Boissonnas
Ruder Finn
P: 1 212-593-6396
F: 1 212-583-2702
CONTACT: Media, Geoff Cook, Novartis Oncology, P: +1-862-778-2675, F:+1-773-781-2074, or Dana Kahn Cooper, P: +1-732-817-1800, F:+1-732-817-1834, or Veronique Boissonnas, Ruder Finn, P: +1-212-593-6396,F: +1-212-583-2702; Investors, Jill Pozarek, Novartis Corporation, P:+1-212-830-2445
Web site: http://www.clinicaltrials.gov/http://www.novartis.com/
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Posted by rob on June 3, 2006 under Uncategorized | Be the First to Comment
Brian Druker, M.D.
ATLANTA, Ga. – The overall survival of most people with chronic myelogenous leukemia (CML) treated with imatinib (Gleevec, STI-571) is extremely high and the relapse rate is quite low, according to new data from a study out of the Oregon Health & Science University Cancer Institute. The overall survival at five years is 89 percent as compared to no more than 50 percent with prior therapies, and the risk of relapse continues to decrease the longer patients take the drug.
"This represents a complete turn around in the prognosis for patients with this disease," said Brian J. Druker, M.D., who originally collaborated with Novartis scientists to develop Gleevec into a successful treatment for CML. He is the JELD-WEN chair of leukemia research in the OHSU Cancer Institute and an investigator of the Howard Hughes Medical Institute.
Druker presented the five-year update from the IRIS (International Randomized IFN vs. ST1571) Study Group on Saturday, June 3 at the 2006 annual meeting of the American Society of Clinical Oncology in Atlanta, Ga.
Begun in June 2000, the phase III trial involved 1,106 subjects at 117 centers in 16 countries. Subjects were in CML's chronic phase, the most common stage of the disease, and had not previously received chemotherapy. Half were randomized to receive Gleevec and half to receive the standard treatment at the time the trial started, interferon-alpha and cytarabine arabinoside. Participants in the interferon arm were later allowed to cross over to Gleevec. Just 3 percent remain on interferon therapy.
"Prior to this, we had to project what the five-year survival data would be and worried that the risk of relapse might increase. With this data, we have increased confidence in this targeted therapy," Druker said.
At five years, the overall survival of the 553 subjects randomized to receive Gleevec as their initial therapy was 89 percent; 95 percent if only deaths related to CML are considered. Just 5 percent of subjects discontinued Gleevec because of side effects. Severe side effects included skin rashes, elevated liver enzymes and fluid retention. More common and less severe side effects included puffiness around the eyes, mild nausea, diarrhea and muscle cramps.
The risk of relapse has trended down during the past three years. In the study's fourth year, fewer than 1 percent of patients progressed from the chronic phase to the accelerated phase or to blast crisis. "This trend, if it holds, coupled with the low risk of relapse, means that the possibility of long-term survival with CML is increasingly likely," Druker said. Druker's scientific and clinical research of the molecular cause of CML was instrumental in the development of Gleevec, a signal transduction inhibitor that interferes with the enzymes that trigger the spread of cancerous cells. It acts on CML by inhibiting an enzyme produced by the BCR-ABL gene that tells cells to grow and divide.
Clinical trials with Gleevec began a new era in cancer treatment in which cancerous cells are targeted based on their molecular abnormality and healthy cells are left unharmed.
"What we hope to do in the future is to apply the Gleevec principle more broadly," said Druker, who serves on the Human Cancer Genome Anatomy Project steering committee. "We need a Gleevec for every cancer."
In 2001, the U.S. Food and Drug Administration (FDA) broke a record for cancer therapy approval by fast-tracking Gleevec, approving it in less than three months for CML patients who failed interferon. It was approved for a rare and difficult to treat abdominal cancer, gastrointestinal stromal tumors (GIST), in 2002. In the following year, it also earned the FDA's approval for use in children, the first new pediatric cancer drug treatment in more than a decade. Gleevec is being studied as a potential therapy for certain types of blood and skin cancers.
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Particulars: ASCO Abstract No. 6506: Long-term benefits of imatinib (IM) for patients newly diagnosed with chronic myelogenous leukemia in chronic phase (CML-CP): The 5-year update from the IRIS study.
This study was funded by Novartis.
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