WHO Drug Information Vol. 20, No. 4, 2006 - World Health ...
WHO Drug Information Vol. 20, No. 4, 2006 - World Health ...
WHO Drug Information Vol. 20, No. 4, 2006 - World Health ...
You also want an ePaper? Increase the reach of your titles
YUMPU automatically turns print PDFs into web optimized ePapers that Google loves.
Regulatory Action and News<br />
The change would have included treatment<br />
of aggressive systemic mastocytosis<br />
in adults. Imatinib mesilate was<br />
designated as an orphan medicinal<br />
product for the treatment of mastocytosis<br />
on 26 August <strong>20</strong>05. The Committee for<br />
Medicinal Products for Human Use<br />
(CHMP) considered that the limited data<br />
provided did not support a positive<br />
benefit-risk balance.<br />
Glivec® is currently indicated for the<br />
treatment of adult and paediatric patients<br />
with Philadelphia chromosome positive<br />
chronic myeloid leukaemia, adult patients<br />
with Philadelphia chromosome-positive<br />
acute lymphoblastic leukaemia, adult<br />
patients with Kit-positive unresectable<br />
and/or metastatic malignant gastro-<br />
274<br />
<strong>WHO</strong> <strong>Drug</strong> <strong>Information</strong> <strong>Vol</strong> <strong>20</strong>, <strong>No</strong>. 4, <strong>20</strong>06<br />
intestinal stromal tumours, and adult<br />
patients with dermatofibrosarcoma<br />
protuberans.<br />
During its meeting on 16–18 October<br />
<strong>20</strong>06, the CHMP recommended an<br />
extension of the marketing authorization<br />
for Glivec® to include treatment of myelodysplastic<br />
syndromes and myeloproliferative<br />
diseases, as well as treatment of<br />
adult patients with hypereosinophilic<br />
syndrome and chronic eosinophilic<br />
leukaemia.<br />
Reference: EMEA Press Release, EMEA/<br />
423844/<strong>20</strong>06, 23 October <strong>20</strong>06. http://<br />
www.emea. europa.eu and www.emea.<br />
europa.eu/humandocs/Humans/EPAR/glivec/<br />
glivec.htm.
Change language