Gleevec Gets FDA Priority Review for First-Line Use in Early CML

News
Article
Oncology NEWS InternationalOncology NEWS International Vol 11 No 10
Volume 11
Issue 10

EAST HANOVER, New Jersey-Novartis Oncology’s Gleevec (ima-tinib mesylate) has been granted priority review by the FDA for use as first-line treatment for newly diagnosed Philadelphia-chromosome-positive (Ph+) chronic myeloid leukemia (CML) in the chronic phase. The previous indication allowed for the treatment only in the later stages of the disease or in chronic phase after interferon-alfa failure. The FDA also granted priority review to an application by Novartis to provide dosing information for Gleevec in pediatric patients with Ph+ CML. Both applications will be decided by December 28, 2002, the company said in a news release.

EAST HANOVER, New Jersey—Novartis Oncology’s Gleevec (ima-tinib mesylate) has been granted priority review by the FDA for use as first-line treatment for newly diagnosed Philadelphia-chromosome-positive (Ph+) chronic myeloid leukemia (CML) in the chronic phase. The previous indication allowed for the treatment only in the later stages of the disease or in chronic phase after interferon-alfa failure. The FDA also granted priority review to an application by Novartis to provide dosing information for Gleevec in pediatric patients with Ph+ CML. Both applications will be decided by December 28, 2002, the company said in a news release.

Recent Videos
Yale’s COPPER Center aims to address disparities and out-of-pocket costs for patients, thereby improving the delivery of complex cancer treatment.
Non-Hodgkin lymphoma and other indolent forms of disease may require sequencing new treatments for years or decades, said Scott Huntington, MD, MPH, MSc.
Fixed-duration therapy may be more suitable for younger patients, while continuous therapy may benefit those who are older with more comorbidities.
Determining the molecular characteristics of one’s disease may influence the therapy employed in the first line as well as subsequent settings.
A 2-way communication between providers and patients may help facilitate dose modifications to help better manage adverse effects.
Treatment with AML depends on a variety of factors, including stage of treatment, transplant eligibility, and mutational status.
The medical characteristics of a patient may heavily factor into the selection of tyrosine kinase inhibition for the treatment of chronic myeloid leukemia.