Clinical update

N C P Cross,1,2,* H E White,1,2 D Colomer,3 H Ehrencrona,4 L Foroni,5 E Gottardi,6 

Jun Imagawa, MD, Hideo Tanaka, MD, Masaya Okada, MD, Hirohisa Nakamae, MD, Prof Masayuki Hino, MD, Kazunori Murai, MD, Prof 

M Talpaz1, R Hehlmann2, A Quintás-Cardama3, J Mercer1 and J Cortes3

Rousselot et al1 recently reported on the According to Stop Imatinib (A-STIM) study evaluating the persistence of major molecular response (MMR) in patients with chronic-phase chronic myeloid leukemia (CP CML) who had discontinued imatinib after prolonged deep molecular remission. They found that 61% of the patients were still in MMR and were treatment free after 36 months, whereas those who lost MMR and restarted tyrosine kinase inhibitor (TKI) therapy all regained MMR. They concluded that loss of MMR is a safe criterion for restarting therapy after TKI discontinuation.

Merrill J Egorin,1,2,3 Dhvani D Shah,1 Susan M Christner,1 Mara A Yerk,4 Kristin A Komazec,4 Leonard R Appleman,2 Robert L Redner,2 Brian M Miller,5 and Jan H Beumer1,6

Abstract
AIMS

Whether cancer is maintained by a small number of stem cells or is composed of proliferating cells with approximate phenotypic equivalency is a central question in cancer biology1. In the stem cell hypothesis, relapse after treatment may occur by failure to eradicate cancer stem cells. Chronic myeloid leukaemia (CML) is quintessential to this hypothesis. CML is a myeloproliferative disorder that results from dysregulated tyrosine kinase activity of the fusion oncoprotein BCR–ABL.

BCR-ABL1 mutations are a common, well-characterized mechanism of resistance to imatinib as first-line treatment of chronic myeloid leukemia in chronic phase (CML-CP). Less is known about mutation development during first-line treatment with dasatinib and nilotinib, despite increased use because of higher response rates compared with imatinib.

This is a summary of the European public assessment report (EPAR) for Imatinib Teva. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of