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news.Novartis has received a positive opinion recommending EU approval of Tasigna (nilotinib), a selective targeted therapy for adult patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase.
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The Committee for Medicinal Products for Human Use (CHMP) recommended approval of Tasigna in the indication based on a pivotal Phase III clinical trial in which Tasigna surpassed Glivec (imatinib) in key measures of treatment efficacy.
In the Phase III clinical study, Tasigna was found superior to Glivec in achieving higher rates of both major molecular and complete cytogenetic response and in delaying cancer progression.
Novartis Oncology Development & Medical Affairs global head Alessandro Riva said that they were glad that the development of Tasigna may result in a new treatment option for newly diagnosed CML patients seeking effective means of preventing disease progression.
“Following this positive opinion from CHMP, we look forward to working with regulatory authorities to bring Tasigna to clinical use in the setting as soon as possible,” Riva said.
Novartis said that the US Food and Drug Administration and Swiss health authority Swissmedic have already approved Tasigna for newly diagnosed Ph+ CML.