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February 2002 (Newstream) — The U.S. Food and Drug Administration on Feb. 1 approved the Novartis drug Gleevec™ (imatinib mesylate)* for the treatment of patients with Kit (CD 117) positive unresectable (inoperable) and/or metastatic malignant gastrointestinal stromal tumors (GISTs). The effectiveness of Gleevec in GIST is based on the objective response rate. There are no controlled trials demonstrating a clinical benefit, such as improvement in disease-related symptoms or increased survival.
Prior to the availability of Gleevec, patients with GISTs had no effective treatment options beyond surgery. Gleevec was approved in the U.S. on May 10, 2001, for its initial indication as a treatment for a specific type of leukemia. According to Daniel Vasella, MD, chairman and CEO of Novartis, "Gleevec has already made a major difference in the lives of patients with chronic myeloid leukemia and we're extremely gratified to now make this drug available to patients with GIST." Dr. Vasella continued, "Novartis — along with our colleagues in academia and government — continues to study Gleevec and investigate other cancers in which it may help patients — either alone or in combination with other therapies." GISTs are the most common malignant form of sarcoma that arise in the gastrointestinal tract, affecting an estimated 2,000 to 5,000 patients in the United States. Historically, they have been very difficult to treat due to their high levels of resistance to treatment with traditional chemotherapy and radiation therapy. For patients with metastatic or unresectable disease, GISTs had represented an incurable malignancy with a median survival of approximately 10 to 12 months. Until now, surgery has been the only effective treatment option, resulting essentially in palliation of the disease. The limited prevalence of GIST has resulted in the FDA designating Gleevec as an Orphan Drug for this indication. "This is the first time we have seen such encouraging results in a drug used to combat GISTs," said George Demetri, MD, Dana-Farber Cancer Institute and lead investigator on the Phase II international study. "Gleevec represents the most major advance to date for a patient population that has had no alternative other than surgery for treating this resistant disease." About Gleevec and GISTs The FDA approval for the GIST indication is supported by data from an open-label, multinational study conducted in 147 patients with unresectable or metastatic malignant GISTs. Patients were randomized to receive either 400 mg or 600 mg of Gleevec daily for up to 24 months. The overall response rate was 38-percent (400 mg = 33 percent; 600 mg = 43 percent), based on confirmed partial responses at the time of the data cut-off for the submission. Gleevec, a signal transduction inhibitor, is one of the first cancer drugs to be developed using rational drug design, based on an understanding of how some cancer cells work. Gleevec targets the activity of certain enzymes called tyrosine kinases that play an important role within certain cancer cells. The activity of one of these tyrosine kinases, known as c-kit, is thought to drive the growth and division of most GISTs. Novartis also has submitted a supplemental filing application for Gleevec to health authorities in the European Union and in Switzerland for the GIST indication. Gleevec To Date Gleevec received FDA approval for the chronic myeloid leukemia (CML) indication on May 10, 2001 for the treatment of patients in the blast crisis, accelerated phase, or in chronic phase after failure of interferon-alpha therapy. The effectiveness of Gleevec in CML is based on overall hematologic and cytogenetic response rates. As yet, there are no controlled trials demonstrating a clinical benefit such as improvement in disease related symptoms or increased survival. For CML, Gleevec is currently approved for marketing in the European Union and in more than 60 countries, including Japan, Switzerland and Australia. In the treatment of CML, it is designated as an Orphan Drug in the United States, European Union and Japan. Contraindications And Adverse Events Although the majority of patients had adverse events reported at least once during the trial, most events were of mild to moderate severity. In the GIST trial, drug was discontinued for adverse events in six patients (8-percent) in both dose levels studied. In this clinical trial, the most common adverse events were edema, nausea, diarrhea, abdominal pain, muscle cramps, fatigue and rash. In this trial, seven patients (5-percent) were reported to have gastrointestinal bleeds and/or intratumoral bleeds. Gastrointestinal tumor sites may have been the source of GI bleeds. Gleevec is contraindicated in patients with known hypersensitivity. Women of childbearing potential should be advised to avoid becoming pregnant while taking Gleevec. The foregoing release contains forward-looking statements that can be identified by terminology such as "major difference" "continues to study," "other cancers," "encouraging results," "most major advance" and "is supported by," 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 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 AG (NYSE:NVS) is 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. For further information please consult Novartis. *In the U.S.: Gleevec™ (imatinib mesylate); outside the U.S.: Glivec® (imatinib)
Source: Newstream
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