The United States Food and Drug Administration (FDA) has granted accelerated approval to Novartis Pharmaceuticals Corporation for their agent Tasigna (nilotinib) for the treatment of chronic phase (CP) or accelerated phase (CP) Philadelphia chromosome positive chronic myelogenous leukemia (CML) among patients who are not able to tolerate treatment with Gleevec® (imatinib) or those who have stopped responding to Gleevec. Upon submission of follow-up data from an ongoing trial, the accelerated approval will convert to regular approval for Tasigna.
Tasigna is an agent that inhibits the tyrosine kinase activity of the BRC-ABL oncogene in Philadelphia-chromosome positive cancer. Tasigna is reported to have greater efficacy than Gleevec in Philadelphia-chromosome positive CML; however, further head to head comparisons of Gleevec and Tasigna are necessary to determine superiority of one agent over another.
The approval of Tasigna was based on hematologic and cytogenetic response rates, not clinical benefit such as improvement in cancer-related symptoms or survival. Longer follow-up will provide this data.
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