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news.Novartis has received a positive opinion supporting European Union approval of Tasigna, a selective targeted therapy for patients with chronic myeloid leukemia who are resistant or intolerant to treatment with Glivec.
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The European Commission generally follows the recommendations of the committee for medicinal products for human use (CHMP) and delivers its final decision within three months. The decision will be applicable to all 27 EU member states plus Iceland and Norway.
The CHMP has recommended approval of Tasigna based on positive findings from a pivotal Phase II trial. Data from the Phase II study show Tasigna reduced or eliminated cells carrying the abnormal chromosome in nearly half of patients (49%) with the chronic phase of the disease.
Taken twice daily, Tasigna inhibits production of cells containing an abnormal chromosome by targeting the production of the Bcr-Abl protein. This protein, which is produced by cells containing the abnormal Philadelphia chromosome, is recognized as the key driver of the overproduction of cancer-causing white blood cells in patients with CML.
David Epstein, president and CEO of Novartis Oncology said: “Tasigna represents a tremendous advance for the small number of patients who develop resistance or intolerance to Glivec. We are proud to have leveraged our expertise in targeted therapy to deliver a new treatment option only six years after introducing a breakthrough therapy for this form of life-threatening blood cancer.”