17 december 2013: Lees ook het artikel over goede resultaten van dasatinib en nilotinib bij CML en ALL in vergelijking met Gleevec. 

15 augustus 2011: ik ben kanker-actueel aan het herzien. Met Gleevec, zie onderstaand artikel,  is heel veel meer onderzoek gedaan afgelopen jaren en de opvolgers, Nipent en Sugent  worden ook al weer enkele jaren in de praktijk toegepast. Echter een genezende behandeling voor met name CML is nog steeds niet gevonden. Toch is er wel hoop. Medscape schreef een mooi samenvattend artikel over de huidige stand van zaken bij vormen van leukemie.  Als u hier klikt  kunt u dit artikel vrij inzien. Zo begint dit artikel:

There are a significant number of patients diagnosed with acute leukemia who either fail to achieve remission or who relapse thereafter. Challenges in treating this patient population include accurately assessing prognosis of disease and whether remission can be achieved; assessing the ability of patients to tolerate aggressive salvage therapies; choosing a salvage therapy that is most likely to succeed; and identifying suitable patients for hematopoietic stem cell transplantation. Despite the development of a variety of new investigational therapies, relapsed or refractory acute myeloid leukemia remains a difficult clinical problem. Clinicians will need to consider all currently available approaches, including cytotoxic chemotherapy, targeted agents, and allogeneic stem cell transplantation, to optimize outcomes. Read more>>>>>>

d.d. 8 maart 2002: Verderop op deze pagina worden deze onderstaande studieresultaten bevestigd in een nog groter onderzoek.

d.d. 10 december 2001. Novartis, een wereldwijd gigantisch groot farmaceutisch bedrijf heeft begin dit jaar van de FDA (USA) bij hoge uitzondering groen licht gekregen om het medicijn Gleevec na slechts een Phase I studie op de markt te brengen. Of dat terecht is weten we niet (zie ook andere berichten over Gleevec op deze pagina), maar afgelopen week kwam Novartis met onderstaand persbericht waarin geclaimd wordt dat Gleevec bij Chronische Myolygene Leukemie betere resultaten zou geven dan welke andere vorm van behandelen bij CML dan ook. Ik moet er wel bij zeggen dat wie het persbericht goed leest er nog al wat addertjes onder het gras zitten. Zo zijn de bijwerkingen niet mis te verstaan, wordt tussen de regels even kort aangegeven dat er een Phase II studie is geweest waarin patiënten snel resistent werden voor Gleevec en lijkt het erop dat slechts nieuwe patiënten met CML in een vroege fase hiermee gebaat zouden zijn. Verder valt op, maar dat kan ook nog niet natuurlijk dat schadelijke gevolgen op langere termijn nog niet te meten zijn geweest en dus ook niet te voorspellen zijn. Desalniettemin wel interessant te lezen wat Gleevec in trials doet, want een score van 98% normalisatie van het bloed in drie maanden tijd tegenover 2-24% bij andere behandelingen is wel erg spectaculair.

-- PRESS RELEASE:Novartis Reports Gleevec Study Results >NVS --
Study Reports Outstanding Gleevec(TM) (imatinib mesylate)* Response Rates in Newly Diagnosed Leukemia Patients

ORLANDO, Fla., Dec. 8 /PRNewswire/ -- New data show that use of the Novartis drug Gleevec (imatinib mesylate) in newly diagnosed patients with chronic myeloid leukemia (CML) in the early chronic phase can result in high cytogenetic response rates. Complete cytogenetic response, the elimination of the cancer cells that characterize CML, is regarded as the ultimate goal of CML treatment.
The rates reported are significantly higher than those historically documented with other CML therapies in the same disease setting. The data were presented today at the annual meeting of the American Society of Hematology (ASH) in Orlando.
"These results demonstrate that the greatest cytogenetic response with Gleevec is seen when treating newly diagnosed patients in the chronic phase of CML -- before they receive other therapy," said Hagop Kantarjian, MD, Professor of Medicine, Chairman, Department of Leukemia and Chief, Section of Leukemia Developmental Therapeutics, M.D. Anderson Cancer Center, Houston, Texas.
"Promising response rates such as these are not seen with any other treatment for CML -- we are anxious to see what the final outcome of this study will be."
Data in Newly Diagnosed CML Patients
The data on the use of Gleevec in 47 newly diagnosed patients with early chronic phase CML showed that after three months of treatment, 77% (36 patients) had achieved complete or major cytogenetic responses (Ph<35%). The hematologic response rate (normalization of blood counts lasting for at least four weeks) was 98% (46 patients). In comparison, in previously reported studies of other agents (interferon-alpha alone and interferon-alpha with Ara-C and homoharringtonine [Triple Rx]) 2-24% of patients on other treatments achieved complete or major cytogenetic responses after three months of treatment. Based on these results, the authors suggest that treatment with Gleevec may offer a significantly improved prognosis in early chronic phase CML.
The potential clinical relevance of early treatment with Gleevec is
underscored by other Phase II data documenting mechanisms of resistance. These data will be featured in a plenary session on Sunday, December 9th. They suggest that resistance may occur most commonly in the advanced, or blast crisis phase, of CML and can be the result of any of several well-established mechanisms for cancer drug resistance (e.g., gene mutations, gene amplification). The authors recommend investigation of combination therapy with Gleevec and other agents as a means to overcoming some cases of resistance.

Additional ASH Highlights
There are approximately 100 abstracts about Gleevec that are being presented at this week's ASH meeting. The data offer new and updated information regarding the agent's activity in treating CML and other types of leukemia characterized by abnormalities that Gleevec is believed to inhibit, particularly the Philadelphia chromosome, which characterizes CML in most patients. In addition to the data on its use in newly diagnosed chronic phase CML patients, presentation highlights will include cytogenetic response as a key measure of the drug's ability to impact the disease itself, not just the symptoms. Also
discussed will be the impact of dosing on treatment outcomes.
"In the two years since the first clinical trial data on Gleevec were
presented at ASH 1999, ongoing research with this drug has provided the oncology community with remarkable opportunities to learn about the complex biological mechanisms of CML," said David Parkinson, MD, Vice President of Clinical Research, Novartis Oncology. "Based on this knowledge, we are working with investigators to enhance treatment outcomes for patients."

About Gleevec
Gleevec is one of the first oncology drugs that validates rational drug design based on an understanding of how some cancer cells work. It is a signal transduction inhibitor, which potentially interferes with the pathways that signal the growth of tumor cells. It works by inhibiting the Philadelphia chromosome, the abnormality that characterizes CML in most patients. Gleevec is currently approved for marketing in the European Union and more than 35 countries, including the United States, Switzerland, Japan and Australia.
On October 19, 2001, Novartis submitted a supplementary New Drug Application (sNDA) to the U.S. FDA seeking marketing authorization for Gleevec for the treatment of patients with unresectable (inoperable) and/or metastatic malignant gastrointestinal stromal tumors (GISTs).

Contraindications and Adverse Events
Gleevec is generally well tolerated. The majority of patients treated with Gleevec experienced adverse events at some time. Most events were of mild to moderate grade, but drug was discontinued for adverse events in 1% of patients in chronic phase, 2% in accelerated phase and 5% in blast crisis. Women of childbearing potential should be advised to avoid becoming pregnant while taking Gleevec. The most common side effects included nausea, fluid retention, vomiting, diarrhea, hemorrhage, muscle cramps, skin rash, fatigue, headache, dyspepsia and dyspnea, as well as neutropenia and thrombocytopenia. Serious and severe side effects, such as hepatoxicity (1.1% to 3.5%), fluid retention syndrome (2% to 10%), neutropenia (8% to 46%) and thrombocytopenia (less than 1% to 31%) have also been reported in some patients. There are no long-term safety data on Gleevec treatment.
In most countries where Gleevec is approved, it is indicated for the treatment of patients with chronic myeloid leukemia (CML) in blast crisis, accelerated phase, or in chronic phase after failure of interferon-alpha therapy. The effectiveness of Gleevec is based on overall hematologic and cytogenetic response rates. There are no controlled trials demonstrating a clinical benefit, such as improvement in disease-related symptoms or increased survival.
The foregoing release contains forward-looking statements that can be
identified by terminology such as "new data," "new and updated information," "one of the first oncology drugs that ... " and "new drug application," or similar expressions. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results with Gleevec to be materially different from any future results, performance or achievements expressed or implied by such statements. In particular, management's ability to ensure satisfaction of the FDA's further requirements is not guaranteed and management's expectations regarding further commercialization
of Gleevec could be affected by, among other things, additional analysis of data; new 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; and other risks and factors referred to in the Company's current Form 20-F on file with the Securities and Exchange Commission of the United States. 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.

About Novartis
Novartis Oncology is a business unit within Novartis AG (NYSE: NVS), a world leader in healthcare with core businesses in pharmaceuticals, consumer health, generics, eye-care, and animal health. In 2000, the Novartis Group's ongoing businesses achieved collective sales of CHF 29.1 billion (USD 17.2 billion) and a net income of CHF 6.5 billion (USD 3.9 billion). The Group invested approximately CHF 4.0 billion (USD 2.4 billion) in R&D. Novartis AG is headquartered in Basel, Switzerland. Novartis Group companies employ about 70,000 people and operate in over 140 countries around the world. 

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