After completing a series of preclinical studies, Dr. Druker spearheaded the highly successful clinical trials of
imatinib for CML, which led to FDA approval of the drug in record time.
Not exact matches
This knowledge laid the foundation
for the targeted cancer treatment revolution inaugurated by
imatinib (Gleevec ®), which has made another blood cancer, chronic myelogenous leukemia, a controllable, chronic disease
for many patients.
In the late 1990s, STI - 571 (
imatinib, Gleevec / Glivec) was identified by the pharmaceutical company Novartis (then known as Ciba Geigy) in high - throughput screens
for tyrosine kinase inhibitors.
The use of
imatinib has dramatically improved treatment results
for adults with c - KIT (CD117 positive) GIST.
Studies here are probing questions such as whether and
for how long
imatinib should be taken after surgical removal of GIST tumors.
In 2001
imatinib was approved
for the treatment of chronic myeloid leukemia, a disease that is almost universally caused by a single genetic mutation, known as the Philadelphia chromosome, and its resulting mutant protein.
Efficacy and safety of regorafenib
for advanced gastrointestinal stromal tumours after failure of
imatinib and sunitinib (GRID): an international, multicentre, randomised, placebo - controlled, phase 3 trial.
Geminin overexpression promotes
imatinib sensitive breast cancer: A novel treatment approach
for aggressive breast cancers, including a subset of triple negative
Several targeted drugs (e.g.,
imatinib [Gleevec ®], dasatinib [Sprycel ®]-RRB- are effective
for treating CML because they attack cells with the Philadelphia chromosome, the genetic abnormality that is the hallmark of this type of leukemia.
Novartis unbelievably went as far as paying specialty pharmacies to recommend Tasigna to Medicare and Medicaid patients who were trying to fill prescriptions
for other drugs (potentially generic
imatinib) and to downplay the side effects of Tasigna to patients considering switching drugs.
This work, and that of colleagues Brian Druker and Novartis, led to the development of the kinase inhibitor
imatinib (Gleevec) as primary therapy
for chronic myelogenous leukemia (CML), and the discovery that
imatinib resistance is caused by BCR - ABL kinase domain mutations.
These include
imatinib, sold under the brand name Gleevec
for chronic myeloid leukemia; gefitinib, sold as Iressa
for metastatic non-small cell lung cancer; and sunitinib, marketed as Sutent,
for renal cell cancer and gastrointestinal stromal tumors.
In a significant, yet unusual judgment the Court of Justice of the European Union (CJEU) upheld the General Court's decision (T - 140 / 12; Teva Pharma v. EMA) that had affirmed the European Medicines Agency's (EMA) rejection of Teva's generic drug application
for Glivec ® (active substance -
imatinib), not due to the reference product's own orphan drug exclusivity but in view of orphan drug exclusivity of a similar medicinal product — Tasigna ® (active substance - nilotinib).
However, the General Court upheld the EMA's decision refusing Teva's generic application
for imatinib in view of nilotinib's orphan drug exclusivity pertaining to CML.