Glivec is durable, long-term Ph+ CML therapy

Swiss drug major Novartis says that data published in the most recent edition of the New England Journal of Medicine is further evidence that its oncology agent Glivec (imatinib) is a durable and well-tolerated long-term therapy for patients with blood cancers. The firm added that the findings, which are derived from the IRIS study, indicate that around 90% subjects who received the agent as initial therapy were still alive after five years.

Specifically, the results showed that individuals with newly-diagnosed Philadeliphia chromosome positive chronic myeloid leukemia who were treated with Glivec demonstrated increasing responses to therapy over a five-year period, while the risk of disease progression decreased to 0.6% by the end of the program. In addition, the drug had a safety profile that was consistent with previously-reported assessments, and newly-occurring or worsening grade 3 or 4 hematologic adverse events were infrequent after two and four years of therapy.

The drug is currently approved in over 90 countries, including the USA, the European Union and Japan, for the treatment of all phases of Ph+ CML. EU and US regulators have also cleared it for use as a therapy for metastatic CD117-positive gastrointestinal tumors.