Basel, Switzerland, 3 January 2003 - Novartis announced today that the European Commission (EC) approved Glivec® (imatinib)* as a first-line treatment for adult and pediatric patients with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML), enabling physicians to provide the drug to newly diagnosed patients. This third approval in late December 2002 comes within 14 months of the initial approval of Glivec in the EU and follows a positive opinion from the EU's Committee for Proprietary Medicinal Products (CPMP) received in September 2002.
The EC's approval of Glivec as first-line therapy for adult patients was based on 12-month data from a large head-to-head study comparing Glivec with a combination of interferon-alpha and cytosine arabinoside (IFN/Ara-C), a traditional treatment for CML. In the International Randomized Study of Interferon vs. STI571 (IRIS), patients treated with Glivec - given orally at 400 mg per day - were nine times more likely to achieve a complete cytogenetic response, a major goal of CML treatment, compared with those treated with the combination. In addition, Glivec significantly delayed the time to progression to the more advanced stages of CML.
The pediatric approval was based on a Phase I study of children with Ph+ CML who had failed prior IFN therapy. The results of this study indicated similar efficacy and safety as seen in adults.
"The rapid decision of EU health authorities should allow appropriate newly diagnosed CML patients access to Glivec early in the course of their disease, when its potential benefits are greatest," said David Epstein, President, Novartis Oncology. "In addition, these patients are more likely to benefit sooner from an improved quality of life as compared with those on traditional therapies.
Clinical data
Updated 18-month data from the IRIS study were presented in December 2002 at the annual meeting of the American Society of Hematology (ASH) in Philadelphia, Pennsylvania, and indicated even better results than the 12-month data used to support the approval. The updated 18-month data have not been reviewed by the health authorities.
Following are comparative statistics:
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Cytogenetic Response |
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*no cells detected containing the Ph+ chromosome |
**detection of less than 35% Ph+ cells remaining.
Based on the 12-month data filed with the health authorities, only 2% and 0.7% of patients in the Glivec arm withdrew from the study or crossed over to the IFN/Ara-C arm for tolerability reasons, respectively. In contrast 6% and 23% of patients, respectively, in the IFN/Ara-C arm withdrew from the study or crossed over for tolerability reasons.
Glivec
In most countries in which it is approved, Glivec is indicated for the treatment of patients with Ph+ CML in the blast crisis, accelerated phase or in chronic phase after failure of interferon-alpha therapy. In addition, Glivec was approved by the US Food and Drug Administration for first-line treatment of patients with newly diagnosed Ph+ CML one day after the 19 December 2002 EU approval.
Glivec also received EU approval on 24 May 2002 for the treatment of patients with Kit (CD 117)-positive unresectable (inoperable) and/or metastatic malignant gastrointestinal stromal tumors (GISTs).
Contraindications and adverse events
In the first-line study (IRIS), the safety profile with Glivec at the 12-month follow-up was similar to that of previous Phase II studies in other CML patients with the exception of a lower incidence of myelosuppression. The majority of patients treated with Glivec experienced adverse events at some time. Most events were of mild to moderate grade and treatment was discontinued for adverse events only in 2% of patients in chronic phase, 3% in accelerated phase and 5% in blast crisis. 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. Glivec is contraindicated in patients with known hypersensitivity to imatinib or any of its excipients.
The foregoing release contains forward-looking statements that can be identified by expressed or implied discussions regarding potential additional revenues to Novartis as a result of this new indication for Glivec, or regarding the long-term impact of a patient's use of Glivec. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results with Glivec to be materially different from any future results, performance or achievements expressed or implied by such statements. There can be no guarantee that the approval described above will result in any additional revenues to Novartis. Neither can there be any guarantee regarding the long-term impact of a patient's use of Glivec. In particular, management's expectations regarding Glivec could be affected by, among other things, additional analysis of Glivec 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; 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.
About Novartis
Novartis AG (NYSE: NVS) is a world leader in pharmaceuticals and consumer health. In 2001, the Group's businesses achieved sales of CHF 32.0 billion (USD 19.1 billion) and a net income of CHF 7.0 billion (USD 4.2 billion). The Group invested approximately CHF 4.2 billion (USD 2.5 billion) in R&D. Headquartered in Basel, Switzerland, Novartis Group companies employ about 74,000 people and operate in over 140 countries around the world. For further information please consult http://www.novartis.com.
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Additional information on Novartis Oncology and Glivec can be found at
www.novartisoncology.com or www.glivec.com. Additional media information
can be found at www.novartisoncologyvpo.com.
