Drug news
CHMP recommends approval of Glivec (Novartis) to treat Ph+ ALL
The Committee for Medicinal Products for Human Use (CHMP) recommend that Glivec (imatinib), from Novartis, should be indicated for the treatment of paediatric patients with newly diagnosed Philadelphia chromosome positive Acute Lymphoblastic Leukaemia (Ph+ ALL) integrated with chemotherapy.
The effectiveness of Glivec is based on overall haematological and cytogenetic response rates and progression-free survival in CML, on haematological and cytogenetic response rates in Ph+ ALL, myelodysplastic/myeloproliferative diseases, on haematological response rates in hypereosinophilic syndrome and on objective response rates in adult patients with unresectable and/or metastatic GIST and on recurrence-free survival in adjuvant GIST.