Biomed Middle East

Significant potential of late- and mid-stage Novartis hematology portfolio

novartisLate-breaking abstract to report data from pivotal trial of Tasigna(R) versus Gleevec(R) in newly diagnosed patients with a form of chronic myeloid leukemia – Data from Phase II studies to show the potential of everolimus in a rare form of non-Hodgkin lymphoma and of panobinostat in Hodgkin lymphoma(1)(2) – Oral presentation featuring early data on midostaurin to show promise in FLT3-mutated acute myeloid leukemia(3) – New data to be presented on a Janus kinase (JAK) inhibitor, recently added to the Novartis Oncology pipeline(4)(5) – Two-year data from EPIC trial to demonstrate Exjade(R) continues to significantly reduce toxic iron that can damage the heart of chronically transfused patients(6)

EAST HANOVER, N.J., Dec. 2 /PRNewswire/ — Novartis announced today that new data, including a late-breaking presentation on Tasigna® (nilotinib) 200 mg capsules in a form of chronic myeloid leukemia, demonstrate the strength of the company’s hematology portfolio in advancing the care of patients.

The new data, at the 51st American Society of Hematology (ASH) Annual Meeting and Exposition, highlight the company’s current therapies and investigational agents in 195 studies including 39 oral presentations. Data will be presented on Tasigna, Afinitor® (everolimus) tablets, Exjade® (deferasirox) and pipeline agents including PKC412 (midostaurin), LBH589 (panobinostat), BHQ880 and INCB18424, an oral, selective Janus kinase (JAK) inhibitor that was recently added to the oncology pipeline through a licensing agreement.

“Data presented at ASH will demonstrate the vigorous research underway to explore the best treatment approaches for patients with rare blood cancers and conditions,” said David Epstein, President and CEO, Novartis Oncology and Novartis Molecular Diagnostics. “We expect these data to lay the groundwork for regulatory submissions and provide a roadmap for the initiation of late-stage and pivotal trials.”

The ASH Annual Meeting will feature results from a pivotal head-to-head study comparing the efficacy and safety of Tasigna versus Gleevec® (imatinib mesylate) tablets(*) in adult patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase (Abstract #LBA-1; Tuesday, December 8, 2009 at 7:30 AM CST).

Data from this Phase III clinical trial, ENESTnd (Evaluating Nilotinib Efficacy and Safety in Clinical Trials of Newly Diagnosed Ph+ CML Patients), will show that Tasigna produced faster and deeper responses than Gleevec when used as first-line therapy.

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