Tasigna wins OD status, Novartis expands access

Swiss drug major Novartis says it will expand patient access to its investigational drug Tasigna (nilotinib/AMN107) for subjects in all stages of resistant Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML).

Novartis stated that the global ENACT (Expanding Nilotinib Access in Clincial Trials) will be open to sufferers of Ph + CML who are not responding to Glivec (imatinib), another Novartis drug and the standard of care for the condition. The firm has also brought foward its development schedule for the agent, which it will now submit for US and European Union approval later this year rather than 2007, as previously expected.

According to the Basle-headquartered group, Tasigna represents the next generation of targeted oral therapies designed to be the most selective inhibitor of Brc-Alb, the definitive cause of Ph+ CML. Originated by Novartis, the novel tyrosine kinase inhibitor binds with high affinity to Brc-Alb and 32 out of its 33 possible mutations.